FDA Advisory Committee recommends Ragwitek for Ragweed Pollen Allergy-Merck Inc.
The Allergenic Products Advisory Committee meeting of the FDA has made a positive recommendation of Ragwitek (Short Ragweed Pollen Allergen Extract) from Merck Inc.. Ragwitek is the proposed trade name for the company�s investigational sublingual tablet for the treatment of diagnosed Ragweed Pollen induced Allergic Rhinitis, with or without conjunctivitis, in appropriate adult patients who are candidates for immunotherapy.
The panel voted six to two (with one abstention) that data support the drug's efficacy, and eight to 0 (also with one abstention) in favour of its safety. The FDA is assessing Ragwitek for the treatment of ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age, and a decision is expected during the first half of this year.