Two drugs have February PDUFA dates. The orphan drug caplacizumab and the antibiotic iclaprim.
The FDA approved caplacizumab (Cablivi by Sanofi) on its due date of February 6 as a treatment for acquired thrombotic thrombocytopenic purpura (aTTP). The drug was designated an orphan drug by the FDA. Caplacizumab was approved in Europe last August. In the 30-day, 145 patent, Phase III, HERCULES trial, treatment with caplacizumab resulted in a normalization of the platelet count in 2.69 days compared to 2.88 days with placebo. Patients that received caplacizumab were 1.55 times as likely to have a normalization of the platelet count compared to placebo.
Iclaprim has a PDUFA date of February 13. The drug is being reviewed by the FDA as a treatment of acute bacterial skin and skin structure infections. Iclaprim is also in development for the treatment of hospital-acquired pneumonia. The FDA designated iclaprim as a Qualified Infectious Disease Product and given it a Fast Track designation for the skin and skin structure infections. In the 72-hour, 600 patient, Phase III, REVIVE-2 trial, iclaprim was non-inferior to vancomycin in achieving > 20% reduction of lesion area at 48-72 hours in patients with acute bacterial skin and skin structure infections. 78% of iclaprim patients achieved > 20% lesion clearing compared to 77% of vancomycin patients. Iclaprim is being developed by Motif Bio.
Click here to review updates on seven research updates from last week.
Click here for a listing of notable 2018 approvals.
Click here to review our MONITORING POTENTIAL BUDGET BUSTERS use case about drugs with PDUFA Dates. A key use case for Specialty Pharmacy.
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