BioCentury
ARTICLE | Politics & Policy

Antibiotics working group wants two approval pathways

August 27, 2013 11:55 PM UTC

The Antibiotics Working Group (AWG) said FDA should consider creating two new approval pathways for antibiotics, including a "Staged Approval Pathway" that would allow for conditional approval of prospectively defined subpopulations prior to approval for a broader indication. AWG also proposed creating a "Streamlined Label Expansion Pathway," which would allow sponsors to use a pathogen-specific, small clinical trial to expand the label of an approved antibiotic or to establish superiority over standard of care. The details came in (see BioCentury Extra, May 30).

The AWG was formed earlier this year to lobby Congress and FDA on commercial, regulatory and reimbursement policies that could facilitate the development of new antibacterial drugs. The group comprises four biotech companies: Cempra Inc. (NASDAQ:CEMP), Durata Therapeutics Inc. (NASDAQ:DRTX), Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) and Trius Therapeutics Inc. (NASDAQ:TSRX). Cubist Pharmaceuticals Inc. (NASDAQ:CBST) is acquiring Optimer and Trius (see BioCentury, Aug. 5). ...