Merck, referred to as MSD outside the US and Canada, has announced the FDA acceptance of biologics license application (BLA) of investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet for review.
Data from five studies assessing the efficacy and safety profile of the tablet in adults with ragweed induced allergic rhinitis (with or without conjunctivitis) and 18 years of age or older, is included in the application.
Merck Research Laboratories respiratory and immunology senior vice president, interim franchise head Jeffrey Chodakewitz said, "This regulatory milestone for our investigational ragweed pollen sublingual allergy immunotherapy tablet represents another step in our continued commitment to offering potential new options to allergy specialists and their patients."
The investigational agent was developed to generate immune response against targeted allergen, thereby treating the root cause of allergic rhinitis.
Merck and ALK-Abello are developing sublingual allergy immunotherapy tablets for ragweed pollen, timothy grass pollen and house dust mite in North America.
