Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (Nasdaq: MDVN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI®(enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.

A Type-II variation to update the Summary of Product Characteristics (SmPC) has also been submitted to the European Medicines Agency.

Suggested Articles

Eli Lilly and Incyte are investing heavily in JAK inhibitor Olumiant's chances in atopic dermatitis, but does it stand a chance against Dupixent?

Stinging from a previous trial failure in 2016, AstraZeneca's Brilinta topped solo aspirin in slicing CV risks in heart attack and stroke patients.

Taking over IL-23 inhibitor brazikumab marks a new endeavor for AstraZeneca, as does buying prescription drugs Zenpep and Viokace for Nestlé.