UCB Receives Not-Approvable Letter From FDA For Lacosamide For Diabetic Neuropathic Pain

Main Category: Pain / Anesthetics
Also Included In: Epilepsy;  Neurology / Neuroscience;  Regulatory Affairs / Drug Approvals
Article Date: 31 Jul 2008 - 3:00 PDT

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UCB announced that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults.

The company will seek clarification from the FDA of its position and of the additional information required to obtain final marketing approval.

UCB confirmed that lacosamide (Vimpat®) is also currently under active review by the FDA for the adjunctive treatment of partial onset seizures in patients with epilepsy, age 16 and over.

In June 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending that the European Commission grant a marketing authorization for Vimpat® (lacosamide) for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients with epilepsy, age 16 and over. Vimpat® is also under review by the EMEA for the treatment of diabetic neuropathic pain in adults.

About Vimpat® (lacosamide)

Vimpat® is an investigational therapy for the reduction of pain and discomfort in patients with diabetic neuropathic pain - a common and painful complication of diabetes.

Vimpat® is the first agent of its kind to be clinically studied for the treatment of diabetic neuropathic pain. Preclinical studies indicate that Vimpat® has a novel, dual mode of action.

One aspect of Vimpat®'s mode of action involves a unique modulation of sodium channels in the nervous system. Sodium channels play a crucial role in regulating the activity level of the nervous system. Vimpat® targets an aspect of sodium channels that regulates activity in over-excited cells, with limited effect on normal cell activity.

Vimpat® also binds to the collapsin response mediator protein-2 (CRMP-2). The nature of the interaction between Vimpat® and CRMP-2 is not completely known. Vimpat® is the first drug for which an interaction with CRMP-2 has been described.

Vimpat's® precise mechanism of action in humans remains to be fully elucidated.

About Diabetic Neuropathic Pain

Diabetic neuropathic pain is a painful and potentially debilitating complication of diabetes often characterized by a stabbing or burning sensation in the legs, feet and/or hands. It is caused by damage or dysfunction to the peripheral nervous system as a result of diabetes or impaired glucose tolerance. Diabetic neuropathic pain often substantially interferes with sleep, recreational activities, mobility, and normal work and social activities, and many patients with the condition experience a significantly reduced quality of life. With the overall prevalence of diabetes in the U.S. estimated at 20.8 million people, it is thought that as many as 5 million have diabetic neuropathic pain.

About UCB

UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. Employing approximately 12,000 people in more than 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on the Euronext Brussels Exchange..

Forward looking statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

http://www.ucb-group.com