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U.S. FDA declines to approve Revance’s frown-line treatment By Reuters

by Mike Robinson

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© Reuters. FILE PHOTO – Signage outside the Food and Drug Administration headquarters in White Oak (Maryland, U.S.A), August 29, 2020. REUTERS/Andrew Kelly/File Photograph

(Reuters) – Revance Therapeutics Inc (NASDAQ) said Friday that the U.S. Food and Drug Administration refused to approve Revance Therapeutics long-acting injection drug to treat severe frown lines. It sent Revance Therapeutics shares plummeting 29%

Company claimed that FDA had pointed out “deficiencies” in Revance’s manufacturing facility inspection.

According to the drug developer, there was no additional concern in the “complete response letter” of the agency.

Revance’s DaxibotulinumtoxinA For Injection is a possible rival AbbVie Inc Botox Anti-Wrinkle Injection (NYSE:) was successful at reducing frown lines by moderate to severe in late-stage studies in December 2018.

The U.S. FDA deferred its November 2017 decision because it could not conduct the required inspection at the manufacturing plant due to COVID-19 travel restrictions. Revance stated that it expected approval in 2021.

Revance’s chief executive officer Mark Foley stated that he was very disappointed with the FDA’s unanticipated response and requested clarification from them.

Revance indicated that Revance plans to contact the FDA to resolve the concerns of the FDA.

Shares of the company closed Friday at $22.71 and were $16.20 during extended trade.

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