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Home Industry News UCB withdraws EU application for lacosamide

UCB withdraws EU application for lacosamide

30th September 2008

UCB has announced the withdrawal of its EU marketing authorisation application for lacosamide as a treatment for diabetic neuropathic pain.

The company said it would withdraw its formal application with the European Medicines Agency for the compound – known under the brand name of Vimpat – as a result of a decision by the Committee for the Medicinal Products for Human Use (CHMP).

CHMP said the magnitude of the clinical effect of the compound in this indication has not been convincingly established.

“UCB would need to initiate an additional clinical trial to further substantiate the magnitude of effect of lacosamide in diabetic neuropathic pain,” the company said.

UCB noted the compound has been approved by the European commission as an adjunctive therapy for partial-onset seizures with or without secondary generalisation in epilepsy patients aged 16 or over.

The drug is due to be launched for this condition this month, while it is currently under review by the US Food and Drug Administration in this indication.

In June 2008, UCB announced the results of a clinical trial of lacosamide in patients with fibromyalgia syndrome, with the firm claiming the results were “encouraging” but require further analysis.

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