UPDATE 3-New warnings on Novartis MS pill in Europe and U.S.

* EU review concludes Gilenya benefits outweigh its risks

* EMA and FDA back stronger warnings for heart-risk patients

* Novartis still sees drug as "blockbuster" (Adds U.S. label changes)

LONDON, April 20 (Reuters) - European and U.S. regulators have backed the continued use of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, but said on Friday the drug needed to carry stronger warnings on heart risks.

Novartis said the decision meant the drug remained on-track to be a "blockbuster" - one with annual sales above $1 billion.

Prospects for Gilenya, the first multiple sclerosis (MS) pill of its kind, have been clouded by reports of its association with serious heart problems.

The European Medicines Agency (EMA), which launched a review into the safety of Gilenya in January, said doctors should not prescribe it to patients with a history of cardiovascular and cerebrovascular disease or those on heart-rate lowering medication.

If treatment with Gilenya was considered necessary in these patients, however, their heart activity should be monitored at least overnight following the first dose of the drug, it said.

All patients getting the drug should have an electrocardiogram (ECG) and a blood pressure measurement prior to the first dose and after a six-hour initial period, during which continuous ECG monitoring is recommended.

Novartis has agreed with the Food and Drug Administration that similar warnings be carried on the drug's label in the United States.

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UPDATE 3-New warnings on Novartis MS pill in Europe and U.S.