It looks as though France’s Ipsen and US partner Medicis Pharmaceutical Corp may have to wait a bit longer before getting approval across the Atlantic for Reloxin, the potential rival to Allergan’s Botox.
Marketing approval is likely to be delayed after Ipsen said that the companies are still in “active labelling and risk evaluation and mitigation strategy discussions” with the US Food and Drug Administration related to the Biologics License Application for Reloxin (botulinum toxin type A) “in both therapeutic and aesthetic indications”. A decision was due after the agency extended its review of the product in January to April 13.
Ipsen gave no details as to when the FDA is now thinking of giving its verdict on Reloxin which is being reviewed for aesthetic use and cervical dystonia, under the brand name Dysport. The agency is scheduled to rule on the product for the latter indication next month.
Analysts do not seem overly concderned about the delay and Sam Fazeli at Piper Jaffray said that approvals for both Dysport and Reloxin “could come around a similar timeframe of mid-year”. He added in a research note that this would be “incrementally positive, as it would bring Reloxin’s approval timeline forward by around three months on our current expectations”.
Ipsen and Swiss partner Galderma already have approval to sell Reloxin, under the trade name Azzalure, in Europe for the temporary improvement of moderate-to-severe glabellar lines – vertical lines between the eyebrows.
