FDA News Roundup: Bristol-Myers Squibb, Bayer, Astellas, And More

By Anna Rose Welch, associate editor

What FDA decisions have you missed in the last week?

Bristol-Myers Squibb Immunotherapy Gets Green Light

Bristol-Myers Squibb beat Merck in the race to approval for its immunotherapy targeting non-small cell lung cancer (NSCLC). In December 2014, Opdivo (nivolumab) was approved to treat melanoma, following in the footsteps of Mercks Keytruda. However, three months ahead of the expected action date, the FDA approved Opdivo to treat those with NSCLC who saw their disease progress following platinum-based chemotherapy. In a Phase 3 study, the PD-1 inhibitor proved its ability to extend survival compared to docetaxel. Analysts expect the drug to bring in upwards of $1.7 billion next year, with the promise of earning $7.3 billion by 2020.

Bayer BLA Accepted For Review

Bayers BLA for its hemophilia A candidate, BAY 81-8973 (Kovaltry), has been accepted for review by the FDA. The recombinant Factor VIII compound has been investigated in children and adults in the LEOPOLD clinical trial program. Patients enrolled in the trial were treated with the drug two and three times a week in order to determine the drugs pharmacokinetics, efficacy, and safety.

FDA To Review Actelion NDA

Actelion expects to receive an answer from the FDA for its NDA for Uptravi (selexipag) for pulmonary arterial hypertension (PAH) by December 2015. The drug, the first selective oral prostacyclin IP receptor agonist, has been studied in the Phase 3 GRIPHON study enrolling 1,156 PAH patients. Taken twice daily, the drug was successful in reducing morbidity/mortality events compared to placebo.

Axsome Therapeutics Wins Fast-Track Designation

AXS-02, Axsomes oral, first-in-class, non-opioid treatment for complex regional pain syndrome (CRPS), has been granted fast-track designation. The drug was previously named an Orphan Drug by the FDA and the EMA for treating severe pain associated with CRPS.

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FDA News Roundup: Bristol-Myers Squibb, Bayer, Astellas, And More