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FDA staff says Allergan's new dermal filler effective
April 30, 2013 / 1:55 PM / 5 years ago

FDA staff says Allergan's new dermal filler effective

April 30 (Reuters) - Reviewers for the U.S. Food and Drug Administration said Allergan Inc’s dermal filler, Juvéderm Voluma XC, was effective in correcting volume deficit in the middle of the face at six months of treatment.

The reviewers said that if the filler was approved, the company should be required to do a post-approval study to test the safety of a repeat treatment. ()

The FDA staff also said that a scale -- used to measure the overall volume change in patients’ mid face -- has not been used before for an approval, and the two reviewers often did not agree on the rating of a given patient using the score.

An independent advisory panel will be voting on the filler’s safety, efficacy and risk-benefit profile on May 2, and the panel will be asked to comment on the reliability of the scale and the meaningfulness of a one point change on the scale.

“Based on Allergan’s solid product approval track record, the established safety/efficacy profile of Juvederm and the briefing material, we expect a generally positive panel and see likely FDA clearance later this year,” Wells Fargo Securities analyst Larry Biegelsen wrote in a note.

Allergan’s popular injectable gel filler Juvéderm was approved in 2006 to correct moderate to severe facial wrinkles and folds.

Juvéderm Voluma XC is being developed to be used as a dermal filler in the midface, a significant new indication. The company also sells several other fillers as part of the Juvéderm line of products.

Allergan shares were trading almost flat at $113.76 in morning trade on the New York Stock Exchange.

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