Goodbye Injections and Sneezes: FDA Approves Merck’s Allergy Tablet
Merck & Co. Inc. (NYSE:MRK) received FDA approval for the first of three allergy medicines in its line-up on Monday; the drug, called Grastek, targets grass pollen allergies specifically, according to a Merck press release and a recent Reuters report.
Merck developed the immunotherapy drug in partnership with Denmark’s ALK Abello, and expects to launch the drug, which has been approved for patients ages 5 to 65, in the United States by the end of April.
Immunotherapy drugs are a type of medicine which work by boosting the body’s immune system. In the case of Merck’s allergy medicine, the body actually becomes less sensitive to allergens; the drug actually contains some timothy grass extract and dissolves when placed under the tongue, according to Reuters.
“This important milestone marks another opportunity for Merck to build on our respiratory heritage with allergy specialists,” said Dr. Sean Curtis, vice president of respiratory and immunology at Merck Research Laboratories, in a press release Monday.
Merck notes in its press release that many patients affected by grass pollen allergies decline allergy shots, despite being candidates for immunotherapy. “With the FDA approval of Grastek, allergy specialists now have a new sublingual [under the tongue] approach to offer those patients for their grass allergies,” said Dr. David Bernstein, a professor of medicine and environmental health at the University of Cincinnati College of Medicine, in the press release.
Merck says it estimates that the potential U.S. market for its new allergy medicines is around 3 million patients, and will eventually be worth as much s $1 billion in annual sales, according to Reuters.
Grastek was unanimously approved by an FDA panel in December; panelists then also recommended additional studies be undertaken to test the drug’s safety in children, given the potential side effects, which included throat irritation, oral blistering, and lip swelling.
Grass pollen is one of the most common types of allergies, and Merck notes that timothy grass, one of the most common grasses in the U.S., has been shown to be cross-reactive with other grasses.