WHITEHOUSE STATION, NJ, USA I December 12, 2013 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of the Allergenic Products Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to discuss GRASTEK® (Timothy grass pollen allergen extract). GRASTEK is the proposed trade name for the company’s investigational sublingual tablet for the treatment of Timothy grass induced allergic rhinitis, with or without conjunctivitis, in appropriate adult and pediatric patients who are candidates for immunotherapy.
“We are pleased with the positive discussion of GRASTEK at today’s advisory committee meeting,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “We believe GRASTEK has the potential to be an important new oral therapeutic option for allergy specialists and their patients who continue to suffer with Timothy grass pollen induced allergic rhinitis, and we look forward to continuing to work with the FDA as the agency completes its review of our biologics license application for GRASTEK.”
The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. Merck anticipates the FDA’s review of GRASTEK to be completed in the first half of 2014.
GRASTEK is designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect patients against Timothy grass pollen.
Merck has partnered with ALK-Abello to develop its investigational sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite induced allergic rhinitis in North America.
About Merck
Today’s Merck is a global healthcare 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 consumer care 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
SOURCE: Merck
Post Views: 281
WHITEHOUSE STATION, NJ, USA I December 12, 2013 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of the Allergenic Products Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to discuss GRASTEK® (Timothy grass pollen allergen extract). GRASTEK is the proposed trade name for the company’s investigational sublingual tablet for the treatment of Timothy grass induced allergic rhinitis, with or without conjunctivitis, in appropriate adult and pediatric patients who are candidates for immunotherapy.
“We are pleased with the positive discussion of GRASTEK at today’s advisory committee meeting,” said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “We believe GRASTEK has the potential to be an important new oral therapeutic option for allergy specialists and their patients who continue to suffer with Timothy grass pollen induced allergic rhinitis, and we look forward to continuing to work with the FDA as the agency completes its review of our biologics license application for GRASTEK.”
The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. Merck anticipates the FDA’s review of GRASTEK to be completed in the first half of 2014.
GRASTEK is designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect patients against Timothy grass pollen.
Merck has partnered with ALK-Abello to develop its investigational sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite induced allergic rhinitis in North America.
About Merck
Today’s Merck is a global healthcare 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 consumer care 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
SOURCE: Merck
Post Views: 281
