Gilenya MS drug rejected by UK

The UK’s health-cost agency rejected Novartis’s multiple sclerosis pill Gilenya, denting the company’s ambitions to turn the …

The UK’s health-cost agency rejected Novartis’s multiple sclerosis pill Gilenya, denting the company’s ambitions to turn the drug into a multibillion- dollar-a-year earner.

Novartis failed to show that Gilenya reduces relapses sufficiently to justify the annual cost of about £19,196, or that it would be better than existing treatments, the National Institute for Health and Clinical Excellence (Nice) said yesterday.

Gilenya, approved in Europe in March as the first oral treatment for MS, is among the products that Switzerland-based Novartis is counting on to fuel sales growth as patents start to expire on its best-selling treatments.

“It’s absolutely expected that Nice would not back it,” Gbola Amusa, an analyst at UBS in London, said. “Nice is the most conservative major reimbursement agency globally, and Gilenya is one of the most expensive modern medicines in a category that has a number of alternatives.”

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Novartis submitted data that focused mainly on a subgroup of patients who experienced relapses while taking either a placebo or Biogen Idec’s Avonex, which belongs to a class of drugs called beta interferons and isn’t widely used in the UK, Nice said. Novartis should have submitted data comparing Gilenya with other beta interferons and with Tysabri, a rival MS drug, Nice said. – (Bloomberg)