The FDA, which gave its nod to 22 treatments last year, has given its approval to 5 drugs so far in 2017. This includes Synergy’s Trulance (treatment of chronic idiopathic constipation (CIC) in adults), Amgen’s (AMGN – Free Report) Parsabiv (treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis), Marathon’s Emflaza (Duchenne muscular dystrophy), Valeant’s (VRX – Free Report) Siliq (moderate-to-severe plaque psoriasis) and Lexicon’s Xermelo (treatment of carcinoid syndrome diarrhea).

Here is a look at a few important regulatory events scheduled for the month of March.

First up is drugmaker Merck & Co., Inc. (MRK – Free Report) which is awaiting two FDA decisions this month for its anti-PD-1 therapy, Keytruda. While a decision regarding the approval status of Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer is expected by Mar 8, a decision regarding the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients with cHL who have relapsed after three or more prior lines of therapy should be out by mid-March. Keytruda, one of Merck’s new products, is already approved for different types of cancer and brought in sales of $1.4 billion in 2016. Merck is working on expanding the label of the product. Merck, a Zacks Rank #3 (Hold) stock, has outperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 26.5% compared to the industry gain of 6.6%.

 

Roche Holding AG (RHHBY – Free Report) will also be getting a response from the FDA for Ocrevus (ocrelizumab) — the FDA action date for this candidate was extended by three months to Mar 28, 2017 in Dec 2016. The extension resulted from additional data submitted by Roche related to the commercial manufacturing process for the drug. Roche is looking to get the drug approved for relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Roche, a Zacks Rank #5 (Strong Sell) stock, has underperformed the Zacks-categorized Large Cap Pharmaceuticals industry over the last one year with the company’s shares gaining 3.1% compared to the industry gain of 6.6%.

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