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Key FDA Regulatory Events to Watch Out for in Sep 2017

The FDA, which approved 22 novel drugs last year, has given its approval to 31 drugs so far in 2017 including five in August. 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.

A recent landmark approval was that of Novartis’ Kymriah, making it the first gene therapy in the United States. This marks the beginning of a new era for the treatment of cancer and other serious and life-threatening diseases.

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 September.

Will the FDA Follow the Advisory Panel Vote for Mylan’s Herceptin Biosimilar?

Mylan NV MYL should hear from the FDA soon about the approval status of its biosimilar version of Roche’s blockbuster drug, Herceptin (trastuzumab). The company and its partner, Biocon Ltd. got a favorable vote (16-0) from the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) in July for the biosimilar. Herceptin is approved for a wide range of indications including HER2+ breast cancer in the metastatic and adjuvant settings.

Earlier this year, Mylan had entered into a global settlement agreement with Roche’s Genentech, and F. Hoffmann-La Roche Ltd. for Herceptin (trastuzumab), under which Mylan got global licenses (excluding Japan, Brazil and Mexico) for its trastuzumab product. Mylan could well be the first to launch a biosimilar version of Herceptin in the United States. Approval would boost investor sentiment for the company which has lost 17.3% year to date versus the 17.9% decline of its industry.

FDA Advisory Panels to Discuss Glaxo, Pfizer & PTC Therapeutics Drugs

Quite a few FDA advisory panel meetings are scheduled for this month. The FDA’s Vaccines and Related Biological Products Committee (VRBPAC) will be meeting on Sep 13 to discuss the safety and effectiveness of GlaxoSmithKline plc’s GSK Shingrix. Glaxo is looking to get the non-live, recombinant vaccine approved for the prevention of herpes zoster (shingles) in people who are 50 years old or above. Shingles, a common and potentially serious condition, can cause lasting pain and other complications such as scarring or visual impairment.

Then on Sep 19, the FDA’s ODAC will be meeting to discuss the supplemental new drug application (sNDA) submitted by Pfizer PFE for its cancer drug, Sutent. Pfizer is looking to expand Sutent’s label for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (“RCC”) following nephrectomy (surgical removal of the cancer-containing kidney). The FDA is expected to render a final decision regarding the label expansion in Jan 2018. Sutent brought in sales of $529 million in the first half of 2017.

Later this month, on Sep 28, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss PTC Therapeutics’ PTCT new drug application (“NDA”) for Translarna (ataluren) for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. Translarna is already approved outside the United States. The FDA is expected to give a response regarding the approval status of the drug by Oct 24, 2017.

Will the FDA Grant Approval to Amgen/Allergan’s Avastin Biosimilar?

Amgen AMGN and Allergan are also expecting a decision from the FDA for their biosimilar version of Roche’s cancer drug, Avastin (bevacizumab). With the companies getting a favorable vote from an FDA advisory panel (“ODAC”) recently, chances of gaining approval on the FDA action date of Sep 14 look good. Shares of Amgen have gained 22.2% year to date, significantly outperforming the industry’s rally of 15.9%.

Merck, Bristol-Myers Seek Label Expansion

Merck MRK is looking to expand the label of its anti-PD-1 therapy, Keytruda, for use in the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma. Keytruda is under priority review for this indication with a response expected on Sep 22. Keytruda, which brought in sales of $1.5 billion in the first half of 2017, is a key product in Merck’s portfolio and is being evaluated for a wide range of indications. Merck has gained 8.4% year to date versus the 12.3% growth of its industry.

Bristol-Myers Squibb Company BMY is also looking to expand the label of its PD-1 inhibitor, Opdivo. Opdivo is under priority review for use in patients with hepatocellular carcinoma (“HCC”) after prior treatment with Nexavar (sorafenib). The FDA is expected to give a response on Sep 24, 2017. Opdivo, one of the prioritized brands in Bristol-Myers’ portfolio, brought in sales of $2.3 billion in the first half of 2017. Bristol-Myers has gained 2.5% year to date versus the 12.3% growth of its industry.

Will the FDA Approve J&J’s Plivensia?

Johnson & Johnson’s investigational rheumatoid arthritis (“RA”) treatment, Plivensia (sirukumab), an IL-6 inhibitor, is under FDA review with a response expected on Sep 23. However, early in August, Plivensia failed to get the support of the FDA’s Arthritis Advisory Committee on safety concerns. J&J 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 United States. Although the FDA is not required to do so, it usually follows the advice of its advisory panels. Considering the safety concerns raised by the panel, it’s quite likely that the agency will ask for additional information before granting approval. Shares of J&J have gained 13.7% year to date, outperforming the industry’s rally.

Neos Therapeutics is also awaiting a decision this month for NT-0201, its amphetamine XR liquid suspension product candidate for attention deficit hyperactive disorder (“ADHD”). Approval on Sep 15, 2017 would allow the company to go ahead with its plans to launch the product in Jan 2018.

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