Denmark-based pharmaceutical company ALK-Abello has announced that the FDA Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) will meet on 28 January 2014 to discuss the biologic license application (BLA) for the investigational ragweed sublingual allergy immunotherapy (AIT) tablet.
Merck, the North American partner of ALK-Abello, has submitted the biologic license application in March 2013 to the FDA for the sublingual allergy immunotherapy tablet against ragweed allergy. The FDA has accepted the application in May 2013 for review.
Merck has filed the application based on results from an extensive clinical development program. Data from the clinical studies showed that treatment with ragweed sublingual AIT tablets reduces patients' allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated.
The partnership of ALK-Abello with Merck covers the development, registration and commercialization of a portfolio of sublingual allergy immunotherapy tablets in North America.