ZinplavaTreatment for Prevention of Clostridium Difficile Infection Recurrence
Update: Zinplava (bezlotoxumab) Now FDA Approved - October 21, 2016
Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
KENILWORTH, N.J.--(BUSINESS WIRE) July 21, 2016 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said that the U.S. Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The additional data and analyses constitute a major amendment to the BLA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months. The new goal date will be Oct. 23, 2016.
The FDA granted Priority Review designation to the bezlotoxumab BLA, with an original PDUFA goal date of July 23, 2016. On June 9, the Antimicrobial Drugs Advisory Committee of the FDA voted 10-to-5, with one abstention, in support of bezlotoxumab as showing substantial evidence of efficacy and safety in preventing the recurrence of C. difficile infection.
Merck looks forward to continuing to work with the FDA on the review of the bezlotoxumab BLA.
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.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Source: Merck & Co., Inc.
Posted: July 2016
- FDA Approves Merck’s Zinplava (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection - October 21, 2016
- Merck Statement on FDA Advisory Committee Meeting for Zinplava (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence - June 9, 2016
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