Pill To Stop Allergy For Life Goes Before FDA
The pharmaceutical giant Merck made a press release today indicating that they had filed a Biologics License Application for an allergy immunotherapy treatment. The treatment would offer lifelong protection against allergies in response to Timothy grass pollen (Phleum pratense). Merck also filed paperwork with the FDA in March for a variant of the treatment that would protect against allergies from ragweed pollen (Ambrosia artemisiifolia) allergic immunotherapy tablet.
Phase III clinical trials have been completed and the drug has been shown to be both safe and effective in prevent allergies to the specific grass pollen through a long term, multi-season trial.
"We are pleased to have achieved this important milestone in the development of our investigational grass pollen AIT, which, if approved, would represent a potential new option for allergy specialists to offer appropriate allergic rhinitis patients," said Jeffrey A. Chodakewitz, M.D., senior vice president, Global Scientific Strategy, franchise head, Infectious Diseases and interim franchise head, Respiratory & Immunology, Merck Research Laboratories.
The symptoms of an allergic reaction to grass pollen is itchy nose, runny nose, stuffy nose, sneezing and red eyes, itchy eyes and watery eyes. Grass AIT (Allergy Immunotherapy Tablet)/GRAZAX) and has been approved in 30 European countries. Yet, the Phase III clinical trials investigated use for sites outside of European countries.
The medication is a pill of an extract from the allergen that is placed under the tongueonce a day where it dissolves. Usage would require patients to do this for three years during allergy season. The medication works by training the immune system to attack the allergen a different way, thereby reducing the allergic symptoms and having the patient become immune to specific allergens.
What makes this different is that rather than stopping the mediators of allergy, such as histamine being blocked by diphenhydramine (Benadryl), this actually changes the way the immune system sees the allergen so the body does not have an "allergic response."
The medication is being developed under an agreement with ALK-Abello, (Denmark), to develop, market and distribute tablet-based vaccines against grass pollen, house dust mites and ragweed allergies in the U.S., Canada and Mexico.