Merck & Co submits ragweed AIT BLA to the FDA

US pharma giant Merck & Co (NYSE: MRK) has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for a marketing authorization for ragweed allergy immunotherapy tablet (AIT).

The product is licensed from Denmark-based allergy specialist ALK Abello (ALKB: DC), which says the submission of the BLA entitles ALK to a milestone payment of $5 million from Merck, which has rights to the portfolio of AITs in North America.

The application to the FDA is based on results from an extensive clinical development program. Data from the clinical trials have demonstrated that treatment with ragweed AIT reduces patients’ allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated.