Bloomberg News

Glaxo Epilepsy Drug Trobalt Wins U.K. Health-Cost Agency Backing

June 17, 2011

June 17 (Bloomberg) -- GlaxoSmithKline Plc’s Trobalt epilepsy drug won the backing of the U.K.’s health-cost agency as a treatment option for patients who aren’t helped by existing therapies.

Trobalt, also known as retigabine, is recommended for adults with partial-onset seizures who haven’t responded well to eight other medicines including Glaxo’s Lamictal and Pfizer Inc.’s Neurontin, the London-based National Institute for Health and Clinical Excellence said today in an e-mailed statement. Generic versions of Lamictal and Neurontin are available.

Epilepsy affects as many as 416,000 people in England and Wales, according to the agency, known as NICE. Most patients experience partial-onset seizures, which are caused by too much electrical activity in one part of the brain, and often need to take a combination of medicines to control the disorder, NICE said. Trobalt won NICE’s backing less than three months after getting European regulatory approval.

“While there are a number of effective anti-epileptic drugs already widely available on the National Health Service, people can have different responses to them,” said Carole Longson, director of NICE’s Health Technology Evaluation Centre, in the statement. “It’s therefore very important for doctors to have a broad range of options so they can find the right combination for their patients.”

If NICE doesn’t receive any appeals to the draft guidance, final recommendations to the National Health Service will be published next month. The agency advises the state-run health system on the cost-effectiveness of treatments. A pack of 84 Trobalt tablets, each containing a 50-milligram dose, costs about 19.46 pounds ($31.33), though prices may vary because of negotiated discounts, NICE said.

Brain Channels

Glaxo, the U.K.’s biggest drugmaker, bought global marketing rights to the drug from Valeant Pharmaceuticals International Inc. in 2008. The medicine acts on the brain’s potassium channel, controlling nerve cells so they don’t become overstimulated and cause a seizure. Most current drugs regulate sodium or calcium channels.

Trobalt won marketing approval in the European Union in March. The treatment won regulatory approval on June 13 in the U.S., where it is known as ezogabine or Potiga. The Food and Drug Administration cleared the drug for use as an additional therapy for patients who aren’t helped by current treatments. The FDA delayed a decision on the product twice last year.

--Editors: Jim Silver, David Risser.

To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net


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