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12:00 AM
Mar 09, 2015
 |  BioCentury  |  Regulation

Swift action for MDR bugs

Why Shionogi wants FDA to create a pathogen-based development pathway

Medical societies such as the Infectious Diseases Society of America, governmental regulatory agencies such as FDA and EMA, and politicians agree that the normal process for new drug approval is too lengthy and costly to meet the urgent need for new agents to treat serious infections caused by multi-drug resistant pathogens. However, while EMA has released clear guidance that provides a development pathway for a pathogen-focused indication, FDA appears constrained by its existing rules.

FDA has made some progress in re-evaluating the clinical requirements for approval of new antibacterial agents, but it has not yet clarified the pathway for pathogen-focused development programs.

During a meeting on Dec. 4-5, 2014, FDA's Anti-Infective Drugs Advisory Committee discussed issues related to clinical development programs and trial designs for antibacterial products to treat patients with serious bacterial infections for which there are limited or no therapeutic options. Edward Cox, director of FDA's Office of Antimicrobial Products, said, "We're talking about more streamlined programs, so there will be greater uncertainty around safety and efficacy. But if we think about the need here, it's important for patients who don't have options to be able to balance those benefits and risks."

But none of the FDA proposals presented directly addressed circumstances unique to pathogen-specific infections, and it remains unclear how much and what kind of data would be needed. The committee noted the agency should have flexibility regarding the amount of data required for different indications where there is unmet need, but also said, "the standard for demonstrating the efficacy and safety of drugs should remain the same."

The committee also discussed the NDA for Avycaz ceftazidime/avibactam from Actavis plc and AstraZeneca plc. The FDA proposed, and the committee recommended, approval of Avycaz only for specific infection sites - not for the treatment of infections caused by MDR bacteria at multiple sites for which it was developed. In the end, the committee did not provide much clarity regarding how to develop a new antibiotic for a pathogen-focused indication.

Clarification of the pathway is...

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