Key FDA Events To Watch Out For In August 2017

The FDA, which approved 22 treatments last year, has given its approval to 26 drugs so far in 2017 including 3 in July. Key approvals this year include Gilead's Vosevi (hepatitis C virus), Puma's Nerlynx (to reduce the risk of breast cancer returning), J&J's Tremfya (moderate-to-severe plaque psoriasis), Regeneron/Sanofi's Kevzara (rheumatoid arthritis), Roche's multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi's eczema treatment, Dupixent, Tesaro's PARP inhibitor, Zejula, and BioMarin's Brineura (treatment of a specific form of Batten disease) among others. Some of these drugs have blockbuster potential.

With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of August.

Another New Indication for Bristol-Myers' Opdivo?

Bristol-Myers Squibb BMY is looking to get the label of its PD-1 inhibitor expanded for use in patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer CRC after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The regulatory application is currently under priority review with a response expected on Aug 2, 2017. Opidivo is currently approved for a wide range of indications and brought in sales of $2.3 billion in the first half of 2017. Bristol-Myers has lost 2.6% of its value year to date (YTD) versus the 10.5% growth of its industry.

Some other FDA decisions scheduled for this month include a response regarding Agios Pharmaceuticals, Inc. AGIO and partner Celgene's CELG Idhifa (under priority review for relapsed and/or refractory (R/R) acute myeloid leukemia (AML) with an IDH2 mutation) on Aug 30. Meanwhile, the FDA is expected to decide on the approval status of Valeant's eye drug, Vesneo (latanoprostene bunod) and Adamas' ADS-5102 (treatment of levodopa-induced dyskinesia in people with Parkinson's disease) on Aug 24.

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