A new epilepsy treatment co-developed by GlaxoSmithKline (NYSE:GSK) and a partner has received preliminary approval in Europe. However, its future in the United States remains up in the air.
GSK and drug development partner Valeant Pharmaceuticals International (NYSE:VRX) said Friday that a committee of the European Medicines Agency recommended market authorization for the drug candidate retigabine, which will be marketed as Trobalt. Retigabine has been developed as an add-on treatment of partial onset seizures, a form of epilepsy where a seizure begins in a specific area in one side of the brain. The drug is intended for patients 18 and older.
Epilepsy affects about 50 million people around the world, according to the World Health Organization. A minimum of 250 million people experience at least one seizure in their lifetime and at least 2.4 million new cases of epilepsy occur each year.
GSK, which has its U.S. headquarters in North Carolina’s Research Triangle Park, entered into an agreement in 2008 with Canada-based Valeant that paid Valeant $125 million up front to license and collaborate on the epilepsy drug candidate. GSK will pay Valeant up to $545 million more if the compound reaches certain milestones. Valeant could get an additional $150 million if milestones are reached for backup compounds to retigabine.
Retigabine has received preliminary approval from the Swiss Agency for Therapeutic Products. But the compound, which is called exogabine in the United States, has yet to pass muster with the U.S. Food and Drug Administration. An advisory committee to the FDA last August found that exogabine was safe and effective and recommended approval of the compound.
The committee said that concerns about the inability to urinate in connection with the drug could be mitigated by patient monitoring. Following that recommendation, the FDA asked for a formal Risk Evaluation and Mitigation Strategy, or REMS, for ezogabine. The agency calls for a REMS when it wants a drug company to outline how the benefits of a drug outweigh the risks.
Despite the advisory committee’s recommendation, the FDA in December declined to approve the drug. GSK and Valeant said that they are reviewing the FDA’s concerns and are working to respond.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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