KENILWORTH, NJ, USA I June 9, 2016 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss ZINPLAVA™ (bezlotoxumab), an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the prevention of C. difficile infection recurrence in patients aged 18 years and older.
“We believe that ZINPLAVA has the potential to offer physicians an important new therapy for their patients to help prevent C. difficile infection recurrence,” said Dr. Nicholas Kartsonis, associate vice president, infectious disease clinical research, Merck Research Laboratories. “We look forward to continuing to work with the FDA as it completes its review of our Biologics License Application for ZINPLAVA.”
The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of ZINPLAVA is July 23, 2016.
ZINPLAVA is given in conjunction with standard of care antibiotics that are used in the treatment of C. difficile infection. It is not an antibiotic.
About Merck
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.
SOURCE: Merck
Post Views: 178
KENILWORTH, NJ, USA I June 9, 2016 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss ZINPLAVA™ (bezlotoxumab), an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the prevention of C. difficile infection recurrence in patients aged 18 years and older.
“We believe that ZINPLAVA has the potential to offer physicians an important new therapy for their patients to help prevent C. difficile infection recurrence,” said Dr. Nicholas Kartsonis, associate vice president, infectious disease clinical research, Merck Research Laboratories. “We look forward to continuing to work with the FDA as it completes its review of our Biologics License Application for ZINPLAVA.”
The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of ZINPLAVA is July 23, 2016.
ZINPLAVA is given in conjunction with standard of care antibiotics that are used in the treatment of C. difficile infection. It is not an antibiotic.
About Merck
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.
SOURCE: Merck
Post Views: 178
