Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photosaid on Friday the U.S. Food and Drug Administration had declined to approve its long-actinginjectable drug to treat moderate to severe frown lines, sending its shares plunging 29%.
The company said the FDA pointed to "deficiencies" related to the regulator's inspection of Revance's manufacturing site.Revance's DaxibotulinumtoxinA for Injection, a potential rival for AbbVie Inc's Botox anti-wrinkle injection, was successful in reducing moderate to severe frown lines in a late-stage study in December 2018.
In November last year, the U.S. FDA delayed its decision on the drug, as it was unable to conduct required inspection of the company's manufacturing facility due to COVID-19 travel restrictions. Revance later said it was expecting approval in 2021. "We are very disappointed by this unanticipated response from the FDA and are seeking further clarity from the agency," Mark Foley, the chief executive officer of Revance, said in aRevance said it plans to request a meeting with the FDA as soon as possible to address the agency's concerns.Reporting by Amruta Khandekar; Editing by Maju SamuelSubscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.
But they'll approve a vaccine that has killed more people than all vaccines together.
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