An incremental GAIN
Companies mixed on whether FDA's GAIN guidance will spur new antibiotics
FDA's latest draft guidance for antibiotics ticks a box under the GAIN Act, but companies say it needs a lot more specifics before it will spur the development of new drugs. On the wish list is more clarity on clinical trial endpoints and guidance on surrogate endpoints.
GAIN, which was incorporated into the FDA Safety and Innovation Act that reauthorized prescription drug user fees, provides added exclusivity for antibiotics and earmarks them for Priority Review.
The act also mandated the creation of a pathogen-focused antibacterial drug development pathway and instructed FDA to issue draft guidance on the pathway this year (see BioCentury, Nov. 12, 2012).
The July 1 draft guidance seeks to streamline the development of drugs that treat patients with antibiotic resistant strains or specific pathogens for which no treatment exists. But while FDA provides alternatives to current trial designs, including the potential for adaptive studies, it says little about potential surrogate endpoints that could get new drugs into physician hands earlier.
Also unclear is the size of the required trials and whether or not supplemental safety trials like thorough QT studies are necessary.
The draft guidance is structured as a Q&A document to address "streamlined approaches" and clinical trial designs to develop antibiotics to treat serious bacterial diseases in patients with unmet medical need.
The document notes that to qualify for streamlined development, a