FDA Accepts BLA for Investigational AIT
It has been revealed in a new report that the biologics license application (BLA) by Merck has been accepted by the US Food and Drug Administration.
The application had been put forth for a new allergy immunotherapy tablet (AIT) named Timothy grass pollen (Phleum pratense). It has been found that the same contains the investigational sublingual dissolvable tablet's safety and efficacy data from Phase III trials. The trials also include a multi-season, long-run trial.
As per the findings, the grass pollen (Phleum pratense) AIT has been designed with an aim to generate an immune response that targets the root cause of allergic rhinitis.
The company has formed a collaboration with ALK-Abello for the development of grass pollen (Phleum pratense) AIT in North America.
It has been found that Merck & Co.'s new immunotherapy meant for grass pollen allergy is being tested by the Food and Drug Administration. It is being said that tablet could be dissolved under the tongue and can permanently reduce symptoms of allergy over time.
"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", affirmed Jeffrey Chodakewitz, Merck Research Laboratories senior vice president.
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