FDA says Novartis’ pill-based multiple sclerosis drug works, but has side effects

FDA weighs benefits, risks of Novartis MS pill

WASHINGTON — Federal health regulators said Tuesday a highly anticipated Novartis drug for multiple sclerosis appears effective but carries a number of side effects, including lung and eye problems.

Swiss drugmaker Novartis has asked the Food and Drug Administration to approve its drug Gilenia to treat patients with relapsed multiple sclerosis, which causes tremors and movement problems. The drug is a daily pill and would offer an alternative to older injectable drugs.

FDA reviewers said two studies of the drug “provide substantial evidence for an effect.”

However, FDA staff also noted a number of side effects with the drug, including eye disorders, heart problems and weakened lung function.

Serious side effects occurred in at least 8.5 percent of patients taking Novartis’ drug, compared with 5.8 percent of patients taking older multiple sclerosis drugs.

FDA reviewers complained that there was little data on the long-term effects of using Gilenia.

On Thursday the FDA will ask a panel of experts whether additional safety studies should be required to assess the drug’s risks. The panel will also vote on whether the drug should be approved. The FDA is not required to follow the group’s advice, though it usually does.

In its own briefing documents posted online, Novartis said it would distribute educational materials on using the drug safely to doctors and patients.

About 2.5 million people around the world have multiple sclerosis, a neurological disease that can cause muscle tremors, paralysis and problems with speech, memory and concentration. In the most common form of the disease, patients experience periods of well-being followed by periodic relapses.

Current treatments can reduce the duration and severity of symptoms but require daily or regular shots or infusions.

Physicians who treat multiple sclerosis are mindful of safety problems with other recent treatment for the disease. Biogen Idec’s drug Tysabri was approved for the condition in November 2004 and pulled from the market the next year after cases of a rare but lethal brain inflammation in some patients. It was reintroduced in 2006 under an FDA-approved distribution program.

Shares of Novartis AG rose 27 cents to $45.10 in morning trading.