LONDON Novartis's multiple sclerosis pill Gilenya, one of its top new drug hopes, has been recommended for use in the state health service after a change of heart by the country's healthcare cost-effectiveness watchdog.
Friday's verdict from the National Institute for Health and Clinical Excellence (NICE), whose opinions are also watched closely in other countries, is welcome news for a product that has run into problems recently.
Later on Friday, the European Medicines Agency (EMA) - the body responsible for licensing Gilenya in Europe in March 2011 - is expected to give an update on the safety of the medicine, following an in-depth review.
The safety probe was launched because of reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.
Gilenya represents a significant change in multiple sclerosis (MS) treatment, since existing drugs such as beta interferons and Elan and Biogen Idec's Tysabri must be injected.
NICE initially said it was unclear if the new drug, which is known generically as fingolimod, was any better than existing treatments.
It changed its mind after Novartis presented data showing the benefits of using Gilenya in a subgroup of adults with highly active disease, whose relapses had increased or stayed the same compared with the previous year despite them taking beta interferons.
Carole Longson, director of NICE's health technology evaluation centre, said it was now clear that Gilenya was a cost-effective option for these patients, provided Novartis supplied the drug at the discounted price it previously suggested.
A NICE spokeswoman said the size of the discount remained confidential. The list price for 28 capsules is 1,470 pounds ($2,300) or just over 19,000 pounds per person for a year.
Novartis and Britain's MS Society welcomed the final NICE decision, which is expected to be officially published next month.
Gilenya's convenient dosing and encouraging results in clinical trials are widely expected to make it a popular alternative to current injections.
The average forecast from analysts suggests global sales will reach $2 billion a year by 2015, according to Thomson Reuters Pharma.
Gilenya is the first MS pill of its kind, but competitors in development include BG-12 from Biogen, teriflunomide from Sanofi and laquinimod from Teva.
(Editing by David Holmes)
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