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The U.K.'s health-cost regulator is backing Novartis's (NVS) pill Gilenya for certain adult patients with highly active relapsing-remitting multiple sclerosis.
The independent National Institute for Clinical Excellence, known by its acronym NICE, said Wednesday it is recommending Gilenya, or fingolimod, for use on the publicly funded National Health Service.
"We are pleased to recommend fingolimod as a treatment option for the specific patient population for whom it has been demonstrated to be cost-effective, providing Novartis applies its proposed discount," NICE Director Carol Longson said, without disclosing the price.
Gilenya has been available in the European Union since March 2011 for treating relapsing-remitting MS, the most common type of the disease. The drug was approved in the U.S. in 2010.
Novartis hopes the drug will become one of the leading treatments in the multibillion-dollar market for treating MS due to its easy oral use.
"Novartis welcomes this final decision from NICE, which will allow appropriate patients with highly active relapsing-remitting MS to have access to Gilenya under the NHS in England and Wales," the company said in a statement, adding that it "remains committed to engaging with reimbursement authorities with the goal of ensuring that appropriate patients will have access to the treatment."
Last week, EU and US regulators requested stronger label warnings for Gilenya after conducting reviews of the pill's safety, following reports of heart problems and the death of a patient.
-By Marta Falconi, Dow Jones Newswires; +41 43 443 8043; firstname.lastname@example.org