UCB was dealt a severe setback when the FDA issued a not-approvable letter late Tuesday for lacosamide, an experimental therapy for diabetic neuropathic pain. Shares in the Belgian company tumbled 15 percent on the news. And analysts were buzzing that the agency's action was likely triggered by the drug's efficacy rather than any safety concerns. Lacosamide was being developed as a potential blockbuster that could take the place of Keppra, which will lose patent protection at the end of the year.
"Lacosamide in neuropathic pain was a significant part of the product story on UCB given its sales potential," wrote one analyst. UCB is now facing considerably greater pressure to boost revenue with Cimzia, which has been approved to treat bowel disorder Crohn's disease.
UCB says it is seeking clarification from the FDA on what it needs to do in order to gain an approval for the drug, which is also known as Vimpat. The therapy is also under review as an adjunct therapy for partial onset seizures among epileptics.