FDA Approves New Antibacterial Drug Using Innovative Pathway Established by the ADAPT Act, Legislation Championed by Rep. Gene Green
HOUSTON, TX – The U.S. Food and Drug Administration (FDA) announced Monday that Arikayce, the first antibacterial drug approved under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD Pathway), would be administered for the treatment of a lung disease affecting a limited population of patients whose bodies do not respond to conventional treatment.
The ADAPT Act, which was introduced by Rep. Green and included in the final passage of the 21st Century Cures Act in 2016, established a pathway that would incentivize and accelerate the development of new drugs to treat serious and life-threatening infections in a limited population of patients who lack effective therapeutic options.
“Public health experts have raised alarm about the increase of “Superbugs,” or antibiotic-resistant infections, as a growing public health threat for decades,” said Rep. Green, Ranking Members of the Energy & Commerce Subcommittee on Health and author of the ADAPT Act. “Now, doctors and patients can find relief knowing that regulatory burdens have been reduced and there’s access to new lifesaving antibiotics. The 21st Century Cures Act was an ambitious bill that heavily invested in medical research and enhanced the FDA’s tools to review and approve new medicine. I’m proud of the work we accomplished and look forward to the additional breakthroughs as more drugs are approved.”
More details about the new drug can be read HERE:
Text of the ADAPT Act can be read HERE.