FDA Nod for Merck's Grastek - Analyst Blog

Merck & Co. Inc. MRK announced that the U.S. Food and Drug Administration (FDA) has approved Grastek (timothy grass pollen allergen extract), a sublingual tablet for the treatment of Timothy or cross-reactive grass pollen-induced allergic rhinitis with or without conjunctivitis in patients aged between 5 and 65 years.

The approval was not unexpected considering that in Dec 2013 the FDA's Allergenic Products Advisory Committee had a positive discussion on Grastek.

However, Grastek's label will include a boxed warning regarding severe allergic reactions associated with the drug. Additionally, the product is also contraindicated in several patient populations including those with severe, unstable or uncontrolled asthma, with a history of any severe systemic allergic reaction and history of any severe local reaction after taking any sublingual allergen immunotherapy and a history of eosinophilic esophagitis.

Grastek, the only FDA approved sublingual allergy immunotherapy tablet for children as young as 5 years old, provides an alternative treatment to patients with allergic rhinitis with or without conjunctivitis, caused by Timothy or cross-reactive grass pollens

Merck has several allergy candidates in advanced stages of development. One of the most advanced candidates, currently under FDA review, is Ragwitek (ragweed pollen allergy). A response should be out in the first half of 2014.

Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Alexion Pharmaceuticals, Inc. ALXN, Regeneron Pharmaceuticals, Inc. REGN and Amgen Inc. AMGN. While Regeneron and Amgen carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).