Sohonos FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 18, 2023.
FDA Approved: Yes (First approved August 16, 2023)
Brand name: Sohonos
Generic name: palovarotene
Dosage form: Capsules
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Fibrodysplasia Ossificans Progressiva
Sohonos (palovarotene) is a retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).
- Fibrodysplasia ossificans progressiva is a rare genetic disorder of the connective tissue characterized by heterotopic ossification, which is the abnormal development of bone in areas of the body where bone is not normally present, such as the ligaments, tendons, and skeletal muscles. The disease progresses to cause limited movement, deformities and severe disability.
- Sohonos contains the drug palovarotene, a retinoic acid receptor gamma agonist (RARγ) that works by mediating the interactions between the receptors, growth factors and proteins within the retinoid signaling pathway to reduce new abnormal bone formation.
- FDA approval of Sohonos was based on the pivotal efficacy and safety data from the Phase III MOVE trial which demonstrated palovarotene effectively reduced annualized heterotopic ossification volume compared with no treatment beyond standard of care.
- Sohonos is administered orally, once daily. The dosage can be increased to manage flare-up symptoms.
- The product label for Sohonos carries a Boxed Warning for embryo-fetal toxicity and premature epiphyseal closure in growing pediatric patients.
- Warnings and precautions associated with Sohonos include premature epiphyseal closure, mucocutaneous adverse reactions, metabolic bone disorders, psychiatric disorders, and night blindness.
- Common adverse reactions include dry skin, dry lips, arthralgia, pruritis, pain in extremity, rash, alopecia, erythema, headache, back pain, skin exfoliation, nausea, musculoskeletal pain, myalgia, dry eye, hypersensitivity, peripheral edema, and fatigue.
Development timeline for Sohonos
Further information
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