UCB receives FDA setback for lacosamide

BRUSSELS (Reuters) - Belgian pharmaceutical group UCB (UCB.BR) has received a "not approvable" letter from the U.S. Food and Drug Administration for its drug lacosamide to treat diabetic neuropathic pain in adults.

The Belgian company said in a statement on Tuesday that it would seek clarification from the FDA and determine what extra information may be required to obtain marketing approval.

"It does not mean it is not approvable for ever," a UCB spokeswoman said, adding the company would first have to request a meeting with the U.S. health regulator.

UCB, which reports first-half results on Friday, considers lacosamide as a potential blockbuster follow-up to its epilepsy mainstay Keppra, which will face generic competition at the end of the year.

The drug with the brand name Vimpat has already won a positive opinion from the European Medicines Agency in June to treat epilepsy. Such recommendations are normally endorsed by the European Commission within a couple of months.

The FDA is also reviewing the drug's use for the adjunctive treatment of partial onset seizures in adults.

UCB said last month that it would decide by the end of the year whether to continue tests on lacosamide to treat fibromyalgia syndrome.

Diabetic neuropathic pain is a painful complication of diabetes often characterised by a burning in the limbs, which can interfere with sleep and everyday life, UCB said, adding there were as many as 5 million U.S. sufferers.

(Reporting by Philip Blenkinsop; Editing by Paul Bolding)