February PDUFA Review Update

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.