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Adakveo FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved November 15, 2019)
Brand name: Adakveo
Generic name: crizanlizumab-tmca
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Sickle Cell Disease, Sickle Cell Anemia

Adakveo (crizanlizumab-tmca) is a P-selectin inhibitor for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).

Development timeline for Adakveo

DateArticle
Nov 15, 2019Approval FDA Approves Adakveo (crizanlizumab-tmca) to Reduce Frequency of Pain Crises in Individuals Living with Sickle Cell Disease
Jul 16, 2019FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101)
Jan  8, 2019Novartis Investigational Therapy Crizanlizumab (SEG101) Receives FDA Breakthrough Therapy Designation for the Prevention of Vaso-Occlusive Crises in Sickle Cell Disease
Dec  1, 2018Novartis Announces New Crizanlizumab (SEG101) Data Analysis in Sickle Cell Disease, and Investment in SENTRY Clinical Program
Oct  9, 2018Novartis Analysis Shows Crizanlizumab (SEG101) Increased the Number of Patients Free of Sickle Cell Pain Crises vs Placebo During SUSTAIN Study
Dec 11, 2017Novartis Drug Crizanlizumab Shown to Prolong Time to Patients' First Sickle Cell Pain Crisis in Subgroup Analysis of SUSTAIN Study

Further information

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