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:
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.