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Adakveo Approval History

Reviewed by J.Stewart BPharm. Last updated on Nov 20, 2019.

FDA Approved: Yes (First approved November 15, 2019)
Brand name: Adakveo
Generic name: crizanlizumab-tmca
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Prevention of Vaso-Occlusive Crises (VOCs) in Sickle Cell Disease

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

  • Vaso-occlusive crises occur when the microcirculation is obstructed by sickled red blood cells. Adakveo works by binding to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion.
  • FDA approval of Adakveo was based on the results of the SUSTAIN trial, a 52-week, randomized, placebo-controlled, double-blind study of 198 patients with sickle cell disease and a history of VOCs. Adakveo reduced the annual rate of sickle cell pain crises by 45% compared to placebo (1.63 vs 2.98) and the annual rate of days hospitalized by 42% (4 vs 6.87).
  • Adakveo is administered via intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter.
  • Patients receiving Adakveo should be monitored for signs and symptoms of infusion-related reactions. Adakveo may also cause interference with laboratory tests used to measure platelet counts.
  • Common adverse reactions include nausea, arthralgia (joint pain), back pain, and pyrexia (fever).

Development History and FDA Approval Process 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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