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Alk Abello A/S's Partner Merck & Co Inc Submits BLA for Marketing Authorization of Grass AIT to FDA

Friday, 1 Feb 2013 07:00am EST 

Alk Abello A/S announced that its partner Merck & Co Inc has submitted a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for a marketing authorization for grass allergy immunotherapy tablet (AIT) – a disease-modifying AIT against grass pollen allergy. The product is marketed as GRAZAX in Europe. The partnership with Merck covers the develop­ment, registration and commercialization of a portfolio of AITs in North America. The application to the FDA is based on results from a clinical development program. Data from the clinical trials have demonstrated that treatment with grass AIT reduces patients’ allergy symptoms and their need for symptom-relieving medication and provides a sustained long-term effect after completion of treatment. 

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