As antibiotic-resistant bacterial infections grow more common, few new drugs to treat them are reaching patients. Over the past decade, regulatory and economic challenges have contributed to the decline in antibiotic innovation, and some infections are now untreatable.1
To encourage the development of antibiotics, the Generating Antibiotic Incentives Now Act, or GAIN, extends by five years the FDA exclusivity period, during which antibiotics that treat serious or life-threatening infections can be sold without generic competition. This additional period of exclusivity increases the commercial value of new antibiotics by ensuring that innovative companies have more time to recoup their investment costs.
In September 2012, FDA designated the antibiotic delafloxacin as a qualified infectious-disease product for treating acute bacterial skin and skin-structure infections and community-acquired bacterial pneumonia. Delafloxacin was one of the first antibacterial agents designated under GAIN.
Note: Please refer to Antibiotics Currently in Clinical Development for up-to-date information on qualified infectious disease products (QIDP).
This milestone generated the following responses:
"Fast-tracking drugs like delafloxacin will help decrease the risk of a nationwide, drug-resistant epidemic. As a physician for more than 30 years, I understand the critical need for new medical treatments. Because of the GAIN Act, today marks the first step in that direction."—Representative Phil Gingrey (R-GA)
"Using incentives provided by the new GAIN Act legislation, Rib-X can invent cutting-edge biotech cures that save lives and cut health care costs."—Senator Richard Blumenthal (D-CT)
"The GAIN program was created as a stimulus to help address the urgent medical need and humanitarian need for new lifesaving antibiotics that can combat the growing problem of drug resistance."—Mark Leuchtenberger, former chief executive officer of Rib-X Pharmaceuticals (now Melinta Therapeutics), the company that is developing delafloxacin.
Two qualified infectious-disease products reach developmental milestone
Marketing applications were submitted for two antibiotics—dalbavancin in September 2013 and tedizolid in October 2013—to treat patients with serious skin and skin-structure infections. These two drugs could be approved by FDA for patients as early as 2014. At that time, the antibiotics would receive 10 years of exclusivity, or market protection, in the United States.
1The Pew Charitable Trusts, Infectious Diseases Society of America, Pharmaceutical Research and Manufacturers of America, “Reviving the Pipeline of Life-Saving Antibiotics: Exploring Solutions to Spur Innovation,” conference proceedings, September 22, 2011, Washington, D.C.