San Diego Business Journal

FDA Grants Special Status to Evofem Drug

By Brittany Meiling Wednesday, July 5, 2017
   

A product being developed by local biotech Evofem Biosciences has received a high priority classification from regulators, granting the company a number of perks.

The product, a drug called Amphora, is being studied for contraception and treating sexually transmitted infections. The U.S. Food and Drug Administration designated the research program a “Qualified Infectious Disease Product” for two separate uses: the prevention of gonorrhea and to reduce recurrent episodes of bacterial vaginosis.

The special regulatory status gives Evofem a number of perks that lighten the burden of development and hopefully shorten the path from lab to market. One benefit is being granted “priority review,” which cuts down the time it takes for the FDA to review a drug application from 10 months to about six months.

Being a qualified infectious disease product also makes Amphora eligible for the FDA’s fast-track program, which speeds development. Finally, the new designation gives Evofem extended market exclusivity if Amphora is approved.