Posted by Michael Wonder on 20 Mar 2018
Amplyx Pharmaceuticals receives fourth “Qualified Infectious Disease Product” designation from the FDA for APX001
12 March 2018 - Designation granted for treatment of cryptococcosis provides priority review, fast-track status and five additional years of market exclusivity.
Amplyx Pharmaceuticals today announced that the US FDA has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company’s lead anti-fungal product candidate.
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.
