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Ipsen in anti-wrinkle drug side-effect talks in US

PARIS - French drugmaker Ipsen said on Tuesday it was in talks with the U.S health authority to detail any possible side effects of its anti-wrinkle drug Reloxin before it can win final marketing approval.

The U.S. marketing decision on Reloxin, an injectable botulinum toxin product and possible rival to Allergan’s Botox, was due after the U.S. Food and Drug Administration in January extended its initial review of the drug to April 13.

Ipsen is holding the talks along with its U.S. partner Medicis Pharmaceutical Corp.

Ipsen said the companies were “in active labelling and risk evaluation and mitigation strategy discussions with the U.S. Food and Drug Administration related to the Biologics License Application for Ipsen’s botulinum toxin type A product in both therapeutic and aesthetic indications”.

Analysts have said they expected Reloxin’s marketing approval to come in the second half of this year.

Ipsen officials were not immediately available for further comment.

One Paris-based analyst who declined to be identified said the announcement was “neither good, nor bad news” because it looked like the FDA was to give its approval once Ipsen and Medicis detailed the possible side-effects of the drug.

Ipsen’s Reloxin reduced the appearance of moderate to severe forehead wrinkles and had few side effects in a U.S., a study published last month showed.

Outside the U.S, the anti-wrinkle treatment is already approved in more than 20 countries, including Britain, under the name of Azzalure.

Medicis holds the rights to sell Reloxin in the United States, Japan and Canada, while in Europe the drug is being marketed by Galderma, a joint-venture between Swiss food maker Nestle and cosmetics company L’Oreal.