FDA asks for more info on new Botox indication

The US Food and Drug Administration has delayed approving Allergan's Botox (botulinum toxin type A) for upper limb spasticity in post-stroke  adults, but has not asked for more clinical trials to be conducted on  the drug, which is already used to treat wrinkles.

Allergan submitted its supplemental Biologics License Application for  this indication in the third quarter of 2008. In its complete response  letter, the FDA asked for a risk evaluation and mitigation strategy and  safety update.

Last month, the FDA approved French drug firm Ipsen's Dysport (botulinum  toxin of type A) for both esthetic use as an anti-wrinkle treatment and  medically as a therapy for cervical dystonia (Marketletter May 7). At  the same time, the agency requested that Allergan adopt a similar REMS  for Botox. The FDA said it has not yet reviewed Allergan's submission  and that an approved REMS will be necessary prior to clearing Botox for  upper limb spasticity. The agency also requested that Allergan provide a  product safety update from studies of the drug across all  indications.