UCB says it is withdrawing an application to market Vimpat, as a treatment for diabetic neuropathic pain after receiving a negative response from advisors to the European Medicines Agency.

The Belgian drugmaker said it has taken this decision based on the EMEA's Committee for Medicinal Products for Human Use’ view that “the magnitude of the clinical effect of Vimpat (lacosamide) in DNP has not been convincingly established". Having spoken to the agency, “UCB would need to initiate an additional clinical trial to further substantiate the magnitude of effect of lacosamide in DNP," the company continued.

The firm comes as little surprise seeing as how Vimpat had already received a not approvable from the US Food and Drug Administration in July for DNP, which is often characterised by a stabbing or burning sensation in the legs, feet and hands. Whether this is the end of the line for lacosamide in DNP remains to be seen but analysts at Deutsche Bank issued a research note saying that UCB may be able to eventually gain a label in this indication “should it demonstrate convincing efficacy in a further clinical study".

The most likely road to success for Vimpat is in epilepsy and it has already been approved in Europe as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 and older. A decision is expected from the FDA in epilepsy by the end of the year.

Vimpat is seen as vital, along with the Parkinson’s disease/restless legs syndrome treatment Neupro (rotigotine) and the anti-tumour necrosis factor alpha drug Cimzia (certolizumab pegol). These three drugs need to plug the gap in sales resulting from the loss of patent protection on the allergy drug Zyrtec (cetirizine) last year and the antiepileptic Keppra (levetiracetam) in the next couple of years.

Takeda pulls ramelteon
Meantime Takeda Pharmaceutical Co has withdrawn its marketing application for European marketing approval for the insomnia drug ramelteon.

That decision comes after the CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for ramelteon in May, and Takeda requested a re-examination of the opinion in June. However, the firm has now decided that the chances of ramelteon being approved could be better supported by submission of new data via a fresh filing.

The drug was approved for sale as Rozerem in the USA in 2005.