Debiopharm receives Qualified Infectious Disease designation for Debio 1450 from FDA

Swiss independent pharma company Debiopharm has received Qualified Infectious Disease Product designation for its Debio 1450 from the US Food and Drug Administration.

Debio 1450 treats acute bacterial skin and skin structure infections, and its designation from the FDA gives it access to Priority Review and Fast Track from the regulator, in addition to five years of market exclusivity in the USA. Fast Track designation expedites drug development and priority review gives an accelerated review of marketing authorization.

The drug is an oral/intravenous anti-infective agent, specifically active against staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA). It is currently in a dose-escalation Phase I study in healthy volunteers. It is being developed from the company’s proprietary antibiotic technology platform Fabiotics.