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Evofem Biosciences Says FDA Grants Fast Track Designation For EVO100 - Quick Facts

Biopharmaceutical company Evofem Biosciences, Inc. (EVFM) announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EVO100 for the prevention of urogenital gonorrhea in women.

The Fast Track designation is designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

Gonorrhoea is increasingly antibiotic-resistant and there are currently no FDA-approved prescription products to prevent gonorrhoea. There are 78 million sexually active woman in the U.S. potentially at risk of contracting sexually transmitted infections, including gonorrhoea.

Evofem's pivotal Phase 3 clinical trial of EVO100 for prevention of chlamydia and gonorrhea in women, Evoguard, is currently enrolling 1,730 women in U.S. study sites. The Company expects to complete enrollment by year-end 2021 and to report top-line data in mid-2022.

Positive outcomes could support submission of a New Drug Application to the FDA for these potential indications by the end of 2022, with an anticipated PDUFA date in the third quarter of 2023 due to the expedited review afforded by the Fast Track designation.

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