Amplyx Pharma Receives "Qualified Infectious Disease Product" Designation From FDA

Amplyx Pharmaceuticals develops products for life-threatening infections, including deadly fungal pathogens, and today annouced that the FDA has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company’s lead antifungal product candidate.

The QIDP designation, a provision under the U.S. Generating Antibiotic Incentives Now (GAIN) Act, was approved by Congress in 2012 to offer incentives to companies to bring to market new treatments for deadly infections. These incentives provide APX001 with eligibility for priority FDA review and fast-track status, and an additional five years of market exclusivity under the Hatch-Waxman Act.

Amplyx had previously received QIDP designation as well as orphan drug designation from the FDA for APX001 for the treatment of invasive candidiasis, invasive aspergillosis, and coccidioidomycosis. This new QIDP status expands the eligible population to include the treatment of cryptococcosis.

“Amplyx has now received QIDP designation for all of the qualified fungal pathogens covered by the program, which serves to highlight the broad spectrum of activity of APX001,” said Ciara Kennedy, PhD, CEO of Amplyx. “The associated government incentives will provide a pathway to make APX001 available as quickly as possible to patients who urgently need new treatments, and provide APX001 with market exclusivity for up to 12 years in the United States.”

(Source: Amplyx Pharmaceuticals)