Irvine, California, May 27: Allergan Inc. (NYSE:AGN) has been asked to furnish more information to the U.S. health regulators to sell Botox for the treatment of muscle rigidity and spasticity in people who have suffered strokes.
Items identified by FDA for approval
The Food and Drug Administration (FDA) has sent a ‘complete response letter’ to Allergan regarding the company’s supplemental Biologics License Application (sBLA) for BOTOX.
The FDA has not asked Allergan to conduct additional clinical studies, a request that would have meant the new approval for Botox could have been shelved for years. The health agency has, instead, requested Allergan to provide a risk evaluation and product safety update for Botox, from clinical and non clinical studies of the injection.
The health regulators have proposed revisions to Allergan’s labeling, including enhanced safety information and other clarifications.
The FDA also wants the company to make available the details of a pivotal trial conducted in 1999 and an updated analysis of that trial. Allergan officials said they can comply with the request of re-verification and the analysis in two or three months.
They have also requested for a post approval study of using Botox for muscle loss, irrespective of the cause, in patients aged 2-17 years, besides adults. This would be beneficial in developing a pediatric plan for the treatment of children suffering from spasticity.
“A significant unmet medical need for those suffering from upper limb spasticity exists in the United States. It is estimated that nearly 500,000 Americans each year develop stroke-related spasticity, the majority of which includes upper limb spasticity1,2. And yet about half of those patients receive no treatment for their spasticity,” Scott Whitcup, M.D., executive vice president, Research & Development, and chief scientific officer of Allergan, stated.
“We have already submitted our REMS for BOTOX as we anticipated this requirement as a condition to an approved spasticity indication. We will work expeditiously to provide the FDA with all other information requested in the complete response letter to support a rapid final review of our application for BOTOX as a treatment for upper limb spasticity,” Whitcup further said.
Botox is derived from a sterilized form of botulinum toxin. It works by temporarily paralyzing and stopping muscle movement when injected in approved and labeled doses. The effect usually lasts between 3 and 6.7 months, depending from patient to patient.