April 30 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
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
Allergan shares were trading almost flat at $113.76 in
morning trade on the New York Stock Exchange.