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.

Will J&J RA Drug Win Support of FDA Panel?

The FDA's Arthritis Advisory Committee will be meeting tomorrow to discuss the BLA for Johnson & Johnson's JNJ investigational rheumatoid arthritis RA treatment, Plivensia (sirukumab), an IL-6 inhibitor. The company is looking to get Plivensia approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). RA is a common, chronic, life-long, autoimmune disease that affects about 1.3 million people in the U.S. While new treatment options have entered the market over the last couple of decades, RA patients are still not adequately managed with many left with fewer therapeutic options due to loss of response to available agents, and poor compliance due to inconvenient dosing.

Earlier this week, the FDA had released briefing documents for the meeting which indicate a lot of emphasis will be placed on the safety profile of the drug especially the imbalance in all cause death between Plivensia and placebo. If approved, Plivensia would enter a pretty crowded market given the presence of drugs like Humira, Actemra and Kevzara among others, though its once-monthly dosing schedule could give it an advantage. Shares of J&J have gained 15.2% YTD, outperforming the industry's rally.

Will FDA Follow in EU's Path and Give the Green Signal to AbbVie's Maviret?

AbbVie ABBV also has an important regulatory event coming up with the FDA expected to respond on the approval status of the company's latest hepatitis C virus (HCV) offering this month. Maviret, an investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), is a once-daily ribavirin-free treatment that has the potential to provide a faster path to virologic cure for all major HCV genotypes (GT1-6). Maviret represents blockbuster potential and could help AbbVie gain major market share once approved and launched. We note that Maviret gained EU approval just last week. Shares of AbbVie have gained 11.6% YTD, outperforming the industry's rally.

Third Time Lucky for Dynavax's Heplisav-B?

It's been a great week for clinical-stage immunology company Dynavax Technologies Corp. DVAX which got a favorable recommendation (12-1) from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) for Heplisav-B, a vaccine for immunization against hepatitis B infection in adults. With the positive vote, will it be third time lucky for the company which has previously received two complete response letters for Heplisav-B (one in Nov 2016 and the other in Feb 2013) from the FDA? A decision from the agency is expected on Aug 10. If approved, Dynavax plans to launch the vaccine early next year. Dynavax's shares shot up 71.4% on the positive panel vote and are up a whopping 301.3% YTD, significantly outperforming the industry's10.5% rally.

Pfizer's Xeljanz to Be Reviewed by FDA Advisory Panel

Pfizer PFE has two regulatory events this month -- the first is an FDA advisory panel meeting and the other a PDUFA date. The FDA's Arthritis Advisory Committee will be meeting on Aug 3 to discuss supplemental new drug applications (sNDAs) submitted by the company for its JAK inhibitor, Xeljanz and Xeljanz XR, for the treatment of adult patients with active psoriatic arthritis. Efficacy and safety data and benefit-risk considerations will be discussed by the panel. Xeljanz, currently approved for RA, brought in sales of $927 million in 2016.

Meanwhile, the FDA is expected to give a response regarding the approval status of Pfizer's Besponsa which recently gained approval in the EU. If approved in the U.S., Besponsa will provide a new treatment option for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia ALL, an aggressive type of blood cancer with poor prognosis in adults. According to information provided by Pfizer, the 5-year overall survival rate for patients with relapsed or refractory adult ALL is less than 10%. Pfizer stock has gained 2.1% YTD, lagging the industry it belongs to. Pfizer is a Zacks Rank #3 (Hold) stock -- you can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

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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