Merck Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet
March 27, 2013 8:00 am ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that the Biologics License Application (BLA) for its
investigational Timothy grass pollen (Phleum pratense) allergy
immunotherapy tablet (AIT) has been accepted for review by the U.S. Food
and Drug Administration (FDA). In March, the company also submitted a
BLA to the FDA for its investigational ragweed pollen (Ambrosia
artemisiifolia) AIT.
The BLA for Merck’s grass pollen AIT is supported by Phase III trials
that evaluated the safety and efficacy of the investigational product,
including a long-term, multi-season trial.
“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,” said Jeffrey A. Chodakewitz,
M.D., senior vice president, Global Scientific Strategy, franchise head,
Infectious Diseases and interim franchise head, Respiratory &
Immunology, Merck Research Laboratories.
Merck’s grass pollen (Phleum pratense) AIT is an investigational
sublingual dissolvable tablet designed to help treat the underlying
cause of allergic rhinitis by generating an immune response to help
protect against targeted allergens. Merck has partnered with ALK-Abello
to develop its grass pollen (Phleum pratense) AIT in North
America.
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Merck
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