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Monthly News Roundup - August 2024

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 31, 2024.

FDA Clears Pfizer and Moderna 2024-2025 COVID-19 mRNA Vaccines

On August 22, the FDA approved the latest COVID-19 mRNA monovalent vaccines from Moderna (Spikevax) and Pfizer / BioNTech (Comirnaty) for people 12 years and older, which will target the KP.2 variant of the Omicron strain. Vaccination for children 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine; 2024-2025 formula) is available under FDA Emergency Use Authorization (EUA).

• The CDC recommends that all persons 6 months of age and older receive an updated COVID-19 2024-2025 vaccine. The COVID-19 vaccines like Spikevax or Comirnaty are used to help prevent COVID-19 and complications caused by SARS-CoV-2. The latest mRNA vaccines are now available at U.S. pharmacies and other healthcare facilities.
• The most prevalent COVID variant as of mid-August was KP.3.1.1 of the “FLiRT” variant family. KP.3.1.1 is thought to make up over 37% of cases in the U.S., which is undergoing a late summer surge of the virus.
• The number of doses a person will need depends on the individual's age, vaccination history, and immune system status. Generally, those 5 years of age and older should receive a single intramuscular dose of the 2024-2025 vaccine at least 2 months after their last COVID-19 vaccine dose.
• Approval is based on previous evidence of the effectiveness and safety of the mRNA vaccines, as well as manufacturing and nonclinical data of the KP.2 adapted vaccine against currently circulating Omicron JN.1. sublineages.
• The mRNA vaccines do not contain any live virus particles and cannot give you COVID-19, although it may not protect everyone who receives the vaccine.
• Warnings include severe allergic reactions, myocarditis (inflammation of the heart muscle), pericarditis (inflammation of the lining outside the heart), and fainting. People should not receive the vaccine if they have had a previous severe allergic reaction to the vaccine or any other vaccine ingredient.
• Common side effects can include injection site pain, redness or swelling, tiredness, headache, muscle ache, chills, joint pain, fever, nausea, swollen lymph nodes, decreased appetite, rash, diarrhea, vomiting and dizziness.
• The Novavax COVID-19 2024-2025 (NVX-CoV2705) is a protein-based vaccine formulation that targets JN.1 and has shown cross-reactivity against JN.1 variants like KP.3.1.1. Upon anticipated FDA authorization, the Novavax vaccine will be for use in individuals aged 12 and older to prevent COVID-19.

Needle-free Neffy Spray Cleared for Emergency Allergic Reactions

ARS Pharmaceuticals has announced the approval of Neffy (epinephrine nasal spray) 2 mg, a needle-free, intranasal epinephrine formulation for the emergency treatment of Type 1 allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg (66 lbs) or more. Anaphylaxis involves life-threatening allergic reactions that can occur in minutes.

• Serious allergic reactions and anaphylaxis can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.
• Neffy is an alpha and beta-adrenergic receptor agonist and the first needle-free epinephrine treatment option for patients with severe allergic reactions. Epinephrine reduces wheezing, improves low blood pressure, hives, severe itching and other symptoms of an allergic reaction. Previously, the only other option was using epinephrine injections, most commonly from an autoinjector device (like Epipen or Auvi-Q) or from a syringe.
• The dose is one spray of Neffy (2 mg of epinephrine) into one nostril, either self-administered or given by a caregiver. In absence of clinical improvement or if symptoms worsen, administer a second dose of Neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose. Neffy should always be kept on hand in case of an allergic event.
• After administration, people should seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
• Approval was based on data from five primary registration studies with a 2 mg intranasal dose of epinephrine. All studies endpoints were met and pharmacokinetic and pharmacodynamic data were within the range of approved epinephrine injection products. No serious adverse events were reported in these studies.
• Warnings and common side effects include poor absorption with nasal structural condition, heart disease, abnormal heart rhythms, high blood pressure, hyperthyroidism, Parkinson’s disease, diabetes, and kidney impairment.
• Common side include throat irritation, nose tingling, headache, nasal discomfort, nervousness or anxiety, tiredness, dizziness and sneezing, among others (see FDA Medication Guide).
• Each Neffy contains a single dose of epinephrine with two spray devices per carton. The shelf life is 30 months and allows for temperature exposure up to 122°F (50°C). Commercial availability is expected in early October.

Gilead’s Livdelzi Granted FDA Accelerated Approval to Treat Primary Biliary Cholangitis (PBC)

In August, the FDA granted accelerated approval to Gilead’s once-daily oral Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) in adults. Livdelzi is used in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA. Livdelzi is not recommended for use in people who have advanced liver disease (decompensated cirrhosis).

• Primary biliary cholangitis (PBC) is a rare autoimmune liver disease that affects the bile ducts in the liver and can worsen over time. An autoimmune disease is a disorder where the body attacks its own cells. Treatment for PBC can help slow disease progression and the need for a liver transplant, but it is not known if taking Livdelzi will improve survival or prevent further liver disease. PBC currently has no cure.
• Livdelzi may be beneficial because it helps counteract the liver damage caused by bile acid buildup. Livdelzi is classified as a peroxisome proliferator-activated receptor (PPAR)-delta agonist. It is thought to work by inhibition of bile acid synthesis through activation of PPARδ, a nuclear receptor expressed in the liver. PPARδ activation by Livedelzi reduces bile acid synthesis through fibroblast growth factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol.
• The recommended dose is one 10 mg capsule by mouth once daily.
• The FDA granted accelerated approval from the Phase 3 RESPONSE study with 193 patients and was based on a reduction of alkaline phosphatase (ALP), a marker of bile flow reduction and a predictor of risk for liver transplant and death. Patients received Livdelzi 10 mg (n=128) or placebo (n=65) once daily for 12 months, either with UDCA (94%) or alone (6%).
• Results: In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response (defined as ALP <1.67x ULN; ≥ 15% ALP decrease from baseline; and total bilirubin less than or equal to ULN) at month 12, versus 20% of participants taking placebo. Treatment also led to normalization of ALP (ALP less than or equal to ULN) in 25% of trial participants at month 12 vs. 0% in placebo. A significant reduction in pruritus (itching) from baseline, a secondary endpoint, was seen at month six.
• Serious side effects include bone fractures and changes in liver tests. Avoid use of Livdelzi in patients with complete biliary obstruction.
• The most common adverse reactions (in at least 5% of patients) are headache, abdominal (stomach-area) pain, nausea, abdominal distension, and dizziness.
• The FDA approved Livdelzi under accelerated approval based on a reduction of ALP. Continued approval of Livdelzi may depend upon verification and description of clinical benefit in further clinical trials.

Galderma’s Nemluvio Improves Itch and Sleep Quality in Patients with Prurigo Nodularis

In August, Galderma announced the approval of Nemluvio (nemolizumab) for the treatment of adults with prurigo nodularis. Nemluvio is an interleukin-31 (IL-31) receptor antagonist and is available as a pre-filled pen for subcutaneous (under the skin) injection.

• Prurigo nodularis (PN) is a skin condition that leads to severe skin itch with reddish firm nodules. Areas typically occur on the arms, legs, shoulders, chest and buttocks. Severe itching may also disrupt sleep quality. The cause is unknown, but is thought to be due to changes in the immune system, nerves, and inflammation. It is estimated to affect up to 181,000 people in the U.S.
• Patients with PN have elevated levels of Interleukin 31 (IL-31), a messenger protein (cytokine) that can lead to severe itching and dermatitis. Nemluvio works by inhibiting IL-31 to improve symptoms.
• Approval was based on the OLYMPIA 1 and OLYMPIA 2 clinical trials in over 500 patients with PN. Nemluvio was given by subcutaneous injection every 4 weeks. At week 16, 56% and 49% of Nemluvio-treated patients achieved at least a 4 point reduction in itch intensity (p<0.001) vs. 16% in both placebo groups. Significant and rapid reductions in itch were observed as early as Week 4 (41% vs. 6% and 7% in placebo), and a significant clearance of nodules and improved sleep were also seen at week 16.
• Warnings and precautions include hypersensitivity (allergic) reactions. Common adverse reactions (incidence ≥1%) include headache, atopic dermatitis (eczema) and eczema nummular (discoid eczema).
• The FDA will also review Nemluvio for the treatment of moderate-to-severe atopic dermatitis, with a decision anticipated later in 2024.

Rybrevant Plus Lazcluze Extends Survival in EGFR-Mutated Non-Small Cell Lung Cancer

In August, the FDA cleared Janssen Biotech’s Lazcluze (lazertinib), used in combination with Rybrevant (amivantamab-vmjw) for the treatment of adults with non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread in the body, and with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

• EGFR is a protein found on cells that helps them grow, but a mutation (change) in the gene can cause abnormal cell growth and cancer. EGFR exon 19 deletions (genetic material is missing) and exon 21 L858R substitutions (genetic material is incorrectly arranged) are the most common mutations found in NSCLC, accounting for about 90% of mutations.
• Lazcluze (80 mg and 240 mg tablet) is an oral tyrosine kinase inhibitor (TKI) and Rybrevant is an intravenous targeted, bispecific antibody directed against EGFR and MET receptors.
• Rybrevant is given as an infusion into the vein weekly for 5 weeks, then every 2 weeks starting at week 7. Premedication is recommended to reduce the risk of infusion-related reactions.
• Lazcluze is given as a once daily oral dose. Take Lazcluze any time before Rybrevant when given on the same day. Anticoagulant prophylaxis (blood thinners) should be administered to prevent venous thromboembolic events (blood clots) for the first 4 months of treatment.
• Approval was based on the Phase 3 MARIPOSA study in 1,074 adults that showed Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to osimertinib (Tagrisso). A median progression-free survival (PFS) of 23.7 months (versus 16.6 months) was seen in this patient population. PFS is the length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse.
• The median duration of response (DOR) was 9 months longer with Rybrevant plus Lazcluze versus osimertinib (25.8 months versus 16.7 months), a secondary endpoint of the study.
• The overall response rate (ORR), also a secondary endpoint, was found to be 78% in patients receiving Rybrevant plus Lazcluze (5.4% complete response) and 73% for those receiving osimertinib (3.5% complete response).
• Warnings and common side effects (≥ 20%) include: lung disease, blood clots, rash (which may be severe), nail infection, infusion reactions, muscle and joint pain, mouth sores (stomatitis), swelling, COVID-19, tingling feeling (paresthesia), tiredness and eye toxicity, among others.
• Rybrevant is also approved in combination with carboplatin and pemetrexed in adults to treat mNSCLC with EGFR exon 20 insertion mutations and as a single agent for mNSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Imfinzi Approved to Treat Early-Stage, Non-Small Cell Lung Cancer Before and After Surgery

In August, AstraZeneca announced the approval of Imfinzi (durvalumab) used with platinum-containing chemotherapy for the treatment of adults with non-small cell lung cancer (NSCLC) with tumors (≥ 4 cm and/or node positive) that can be removed surgically with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

• About 80% of patients diagnosed with lung cancer have non-small cell lung cancer (NSCLC).
• In this regimen, patients are treated with Imfinzi plus chemotherapy before surgery (neoadjuvant) and as a single agent after surgery (adjuvant).
• Imfinzi is classified as a programmed death-ligand 1 (PD-L1) blocking antibody.
• Approval was based on the Phase 3 AEGEAN trial with 802 patients with resectable Stage IIA-IIIB NSCLC, irrespective of PD-L1 expression. Patients received either Imfinzi plus chemotherapy or placebo plus chemotherapy every 3 weeks for four cycles prior to surgery, followed by Imfinzi or placebo every 4 weeks (for up to 12 cycles) after surgery.
• Results from a planned interim analysis of event-free survival (EFS) showed a significant 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen before and after surgery (32% data maturity; EFS hazard ratio of 0.68; 95% confidence interval [CI] 0.53-0.88; p=0.003902).
• In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6).
• In studies, Imfinzi was generally well tolerated with no new safety signals in the neoadjuvant and adjuvant settings. The most common adverse reactions (≥ 20% of this studied patient population) was anemia (low red blood cells), nausea, constipation, feeling tired, muscle or bone pain and rash.
• Imfinzi is also approved by the FDA to treat certain types of small cell lung cancer, biliary tract cancer, hepatocellular (liver) cancer and endometrial cancer.

FDA Approves Zurnai, a Nalmefene Auto-Injector to Treat Known or Suspected Opioid Overdose

The FDA has cleared Purdue Pharma’s Zurnai (nalmefene injection) opioid antagonist autoinjector for the emergency treatment of known or suspected opioid overdose. It is used for natural or synthetic opioid overdoses in patients aged 12 years and older with respiratory and/or central nervous system depression. Zurnai delivers a single-dose of 1.5 mg of nalmefene hydrochloride per actuation.

• Recent data from February shows that approximately 90% of opioid overdose deaths were from synthetic opioids (primarily fentanyl).
• Zurnai is intended for immediate administration as emergency therapy in settings where opioids may be present. It is not a substitute for emergency medical care.
• It is administered by autoinjector into the outer thigh, through clothing if necessary. Additional doses may be administered (using a new autoinjector for each dose) if the patient does not respond or responds and then relapses into respiratory depression, every 2 to 5 minutes until emergency medical assistance arrives.
• Warnings and precautions include sudden, severe opioid withdrawal symptoms, risk of recurrent breathing problems, limited effectiveness with partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, and adverse heart effects, among others.
• Common adverse reactions (incidence at least 5%) include feeling hot, hot flush, nausea, headache, dizziness, chills, vomiting, feeling pain from things not usually painful (allodynia), irregular heartbeat, ringing in the ear, ear discomfort, feeling abnormal, burning sensation, and irritability.
• Zurnai is manufactured by Purdue Pharma, who is working to provide Zurnai at no profit to the Company, and is an important addition to Purdue’s Public Health Initiatives.

Tecelra Granted Accelerated Approval as First Engineered Cell Therapy for a Solid Tumor

Adaptimmune Therapeutics announced FDA accelerated approval of Tecelra (afamitresgene autoleucel) for the treatment of adults with synovial sarcoma that has spread or cannot be removed by surgery, who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen. Tecelra is the first engineered cell therapy for a solid tumor malignancy approved in the U.S.

• Synovial sarcoma is a rare, soft tissue cancer, often in the extremities, that most commonly impacts young adults. Most cases of synovial sarcoma are thought to be associated with a gene mutation that results when parts of chromosome 18 and chromosome X join abnormally.
• Tecelra is a T-cell immunotherapy given as a one-time infusion and made from the patient’s own immune cells to recognize and attack the cancer cells. The modified T cells in Tecelra target the antigen MAGE-A4 expressed by synovial sarcoma cancer cells.
• Accelerated approval was based on the SPEARHEAD-1 (Cohort 1) trial with 44 patients that resulted in an overall response rate (ORR) of 43%, a complete response rate of 4.5%, and a 6-month median duration of response (95% CI: 4.6, not reached). Among patients who responded to treatment, 39% had a duration of response of 12 months or longer.
• The Tecelra product label carries a Boxed Warning for cytokine release syndrome (CRS), which may be severe or life-threatening. Warnings and precautions include Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), severe cytopenia, risk of infections, secondary malignancies, hypersensitivity reactions, and the potential for neurologic events in the four weeks following the infusion.
• Common adverse reactions include CRS, nausea, vomiting, fatigue, infections, pyrexia (fever), constipation, dyspnea (shortness of breath), abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, pleural effusion and edema.
• This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Amneal’s Longer-Acting Oral Crexont Cleared to Treat Parkinson Disease

In August, the FDA cleared Amneal’s Crexont (carbidopa/levodopa), a novel formulation of immediate and extended-release carbidopa/levodopa for the treatment of Parkinson disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide or manganese intoxication in adults. There are roughly one million people living with PD in the U.S. with 90,000 new cases diagnosed each year.

• Parkinson disease is a long-term, progressive nervous system disorder that affects dopamine-producing neurons in the brain. It leads to problems with movement, such as tremors, stiffness, slowed walking and impaired balance.
• Immediate-release carbidopa/levodopa formulations eventually lead to less “on time” and can require up to 10 daily doses for effective motor control. Crexont is dosed orally 2 to 4 times daily depending upon previous treatment, response and side effects.
• Crexont contains immediate-release granules of carbidopa and levodopa, with a disintegrant polymer to allow for rapid dissolution. Extended-release pellets contain levodopa with a sustained release polymer to allow for slow drug release, a mucoadhesive polymer for enhanced absorption and an enteric-coating to prevent early disintegration in the stomach.
• Results from the Phase 3 RISE-PD clinical trial demonstrated more “on time” with less frequent dosing, and significantly less "off time” when compared with immediate-release carbidopa/levodopa.
• Warnings include falling asleep unexpectedly during the day, to avoid sudden discontinuation or rapid dose reduction, heart disease monitoring, hallucination/psychosis, impulse control disorders and dyskinesias (abnormal movements). The most common adverse reactions with Crexont (incidence of at least 3%) are nausea and anxiety.
• Crexont formulation and dosage strengths are different from Rytary (carbidopa and levodopa) extended-release capsules approved by the FDA in 2015.
• Commercial availability is expected In September.

FDA Approves Enzeevu, the Fourth Biosimilar to Eylea

Approved in August, Enzeevu (aflibercept-abzv) from Sandoz is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea (aflibercept) indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), a retinal eye disease.

• Enzeevu is NOT currently interchangeable with Eylea. An interchangeable biosimilar is a biologic that can be automatically substituted by a pharmacist for the reference product (in this case, Eylea), depending upon state law, without contacting the prescriber.
• Unlike Eylea, Enzeevu is not indicated for the treatment of patients with macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, or retinopathy of prematurity.
• Enzeevu is administered by intravitreal injection (into the back of your eye) every 4 weeks for the first 3 months and then once every 8 weeks (2 months), but doses differ. It comes commercially as a 2 mg vial kit and pre-filled syringe for intravitreal (into the back of the eye) injection.
• FDA approval of Enzeevu was based on a comprehensive review of scientific evidence that demonstrated the product is highly similar to, and with no clinically meaningful differences from Eylea.
• Warnings and precautions associated with Enzeevu include endophthalmitis (an inflammation and possible infection of the inner eye), retinal detachments, and retinal vasculitis (eye / blood vessel inflammation) with or without occlusion, increases in intraocular pressure (pressure inside your eyes), and risk of arterial thromboembolic (clotting) events.
• Common adverse reactions include eye bleeding, eye pain, cataracts, vitreous detachment (separation of gel-like fluid from retina in eye), vitreous floaters, and increased intraocular pressure.
• Enzeevu is the fourth FDA-approved Eylea biosimilar, following the approvals of Ahzantive (aflibercept-mrbb), Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) in 2024.

Posted August 2024

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