FDA ACTIONS

Dysport Approved. The first neurotoxin approved for neurologic indications in several years, abobotulinumtoxin A (Dysport, Ipsen) has received FDA approval for the treatment for both cervical dystonia and glabellar lines. The drug will be available for aesthetic purposes in May or June and for cervical dystonia during the second half of 2009. Dysport was originally launched in the United Kingdom in 1991 and has marketing authorizations in over 70 countries. In accordance with their agreement, Medicis (which will handle cosmetic marketing) will now pay Ipsen approximately $75 million as a result of FDA approval, and Ipsen will receive a royalty based on sales and a supply price.

Botulinum Toxin Black Box. The FDA will require all botulinum toxin products to contain a boxed warning about adverse effects that could occur if the effects of the toxin extend outside the injection site. According to an agency statement, FDA took the action, "because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids." FDA also has mandated a Risk Evaluation and Mitigation Strategy (REMS) be put in place for all botulinum toxin products. Botox (Allergan), Dysport (Ipsen), and Myobloc (Solstice) are affected. Reportedly, most reports of distant spread of the toxin happened in adult patients who received Botox or Myobloc for unapproved use in spasticity or for cervical dystonia, an approved use.

Fampridine NDA Accepted. An oral therapy for MS could receive FDA approval by year's end. After announcing early this spring that the FDA had refused a new drug application (NDA) for fampridine-SR, Acorda Therapeutics earlier this month said that the agency had accepted a revised NDA and given it Priority review status. Sustained release fampridine has been shown in studies to improve walking ability of patients with MS, according to the company.

Glioblastoma Drug Cleared. While glioblastoma is still considered incurable, FDA approval of Avastin (bevacizumab, Genentech/Roche) makes the condition treatable. The agency approved the indication earlier this month based on data from clinical trials showing that about a quarter of treated patients experienced tumor response, which lasted for about four months. Avastin is also approved for metastatic colorectal cancer and breast cancer.

AD Trial Approved. Blanchette Rockefeller Neurosciences Institute (BRNI) will launch as Phase II trial of Bryostatin for the treatment of Alzheimer's disease patients following FDA approval of the trial design last month. Bryostatin, originally created as an anti-cancer chemotherapy, has shown evidence of efficacy against AD in rodent models. The human trials should begin this summer.

Dissolvable Lamotrigene Green-lighted. A formulation of Lamictal (GlaxoSmithKline) that dissolves on the toungue earned FDA approval this month. Lamictal ODT will be available in 25mg, 50mg, 100mg and 200mg formulations, according to the company.