FDA Approvals for Neuro Drugs Triple in 2008
Alright. Hyperbole acknowledged.
This year, 3 new chemical entities for the treatment of neurologic diseases were approved by the FDA; whereas in 2007, the FDA approved only 1 new drug for a neurologic condition. The agency’s latest nod is for Banzel (rufinamide; Eisai), which was approved on Friday for the adjunctive treatment of Lennox-Gastaut syndrome, an uncommon and notoriously refractory form of epilepsy.
The 2 other neuro drugs approved this year were Xenazine (tetrabenazine; Prestwick), which received approval (via priority review) on August 15 for the treatment of chorea in Huntington’s disease, and Vimpat (lacosamide; UCB), which received standard-review approval on October 28 for the adjunctive treatment of partial-onset seizures in adults.*
Although the IN VIVO Blog points out that there are several more drug applications pending this year at the FDA, none is seeking an indication for a traditionally defined neuro disease.
On May 9, 2007, the FDA approved another neuro drug from UCB, Neupro (rotigotine), for the transdermal treatment of early-stage idiopathic Parkinson’s disease. However, the company stumbled when crystal formation was discovered on its Neupro patches, which necessitated a US recall earlier this year.
* In July, the FDA denied approval for the use of lacosamide in diabetic neuropathic pain.