US biotech Viamet Pharmaceuticals has been granted qualified infectious disease product (QIDP) designation by the US Food and Drug Administration (FDA) for VT-1598, a novel candidate for the oral treatment of coccidioidomycosis, or Valley fever.
QIDP designation provides significant incentives for the development of innovative antimicrobial agents like VT-1598, including the potential for priority review by the FDA, eligibility for fast track status, and a five-year extension of marketing exclusivity.
The FDA granted orphan drug designation to VT-1598 in May for the treatment of Valley fever, which is a systemic fungal infection in the south west of the USA, where the spores of the fungal pathogen Coccidioides live in the soil. There are an estimated 150,000 cases annually and a major need exists for new treatments.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze