New warnings on Novartis MS pill
London, April 20, 2012
European and US 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 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.
A committee of EMA experts said the possible risk of heart problems could be limited by these stronger warnings. "With these risk-minimisation measures in place, the committee concludes that the benefits of Gilenya continue to outweigh the risks," the agency said in a statement.
David Epstein, head of Novartis Pharmaceuticals, said he welcomed EMA's confirmation of Gilenya's positive benefit-risk profile "which also supports our continued belief of the blockbuster potential of Gilenya". - Reuters