Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet
April 12, 2016 4:00 pm ET
KENILWORTH, N.J. – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-8237, Merck’s house dust mite sublingual allergy immunotherapy (SLIT) tablet.
The BLA for Merck’s investigational house dust mite SLIT-tablet is supported by a comprehensive clinical program involving more than 4,000 patients, including two Phase III in-field trials that evaluated the efficacy and safety of MK-8237 in house dust mite-induced allergic rhinitis with or without conjunctivitis.
“We are proud of Merck’s longstanding respiratory heritage and commitment to helping patients with allergies,” said Stuart Green, M.D., vice president, clinical research, Merck Research Laboratories. “This is an important milestone in the clinical development of MK-8237 as a potential new option for adults with house dust mite-induced allergic rhinitis with or without conjunctivitis. House dust mites are a source of a common perennial allergen and frequently live in household objects such as upholstered furniture, bedding and carpeting.”
Merck’s house dust mite SLIT-tablet is an investigational sublingual immunotherapy dissolvable tablet designed to help treat allergic rhinitis with or without conjunctivitis caused by house dust mite-specific allergens. Merck has partnered with ALK-Abelló to develop its house dust mite SLIT-tablet in North America.
For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.
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