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March 31, 2013

New Drug Approvals

Allergen Immunotherapy Tablets


28 MAR 2013

The US FDA has accepted Merck’s biologics license application (BLA) for an investigational allergy immunotherapy tablet (AIT), Timothy grass pollen (Phleum pratense).

The application includes safety and efficacy data of the investigational sublingual dissolvable tablet from Phase III trials including a long-term, multi-season trial.

Merck Research Laboratories senior vice president, global scientific strategy, franchise head, infectious diseases and interim franchise head, respiratory & immunology Jeffrey Chodakewitz said, “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.”

The grass pollen (Phleum pratense) AIT is designed to generate an immune response targeting the root cause of allergic rhinitis.

The company has collaborated with ALK-Abello for grass pollen (Phleum pratense) AIT development in North America.

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