FDA panel unanimously backs safety and effectiveness of 1st pill for multiple sclerosis

FDA panel: Novartis sclerosis drug safe, effective

SILVER SPRING, Md. — Federal health experts said Thursday a first-of-a-kind multiple sclerosis drug from Novartis is safe and effective for controlling tremors and other symptoms of the debilitating disease.

Despite strong support for approval, the panelists said the drug’s side effects would require screening to make sure patients are healthy enough for treatment.

The Food and Drug Administration convened a panel of advisers to review Swiss drugmaker Novartis’ experimental drug Gilenia, which would be the first pill for multiple sclerosis. All of the existing drugs require frequent injections or infusions, and some can cause flulike side effects.

Doctors and patients say more tolerable therapies are needed to treat multiple sclerosis.

“It appears to be a wonderfully effective drug in spite of some of the risk factors involved,” said Cynthia Sitcov, a patient representative on the FDA’s panel. “I know many people with MS who refuse to try injectables and this is an option for them.”

The FDA’s panel voted 25-0 that Gilenia helps reduce relapses of multiple sclerosis, which causes of host of movement and cognitive problems. In a separate vote the panel said unanimously that the proposed dose of the drug appears safe.

The FDA is not required to follow the group’s advice, though it usually does.

Despite an overwhelming endorsement of the drug, panelists had questions about side effects with the drug, including eye disorders, heart problems and weakened lung function.

Panelists said patients should receive their first dose under doctor supervision due to the possibility for sudden heart irregularities. Additionally, patients should receive routine lung function tests since studies of Gilenia have linked the drug to decreased lung function, the panelists said.

Those side effects were less common when patients received the lower of two doses tested by Novartis, and panelists questioned whether an even lower dose might be safer.

Panelists voted 20-5 that Novartis should be required to study a lower dose of the drug.

“I’m not convinced this is the lowest effective dose,” said Dr. Donald Fong of Kaiser Permanente hospital network. “And if it’s not the lowest effective dose, then why should we accept this as the final answer for the patient?”

In a critical vote, the panel said Novartis could conduct the dose study after the drug reaches the market. A requirement to conduct the study pre-approval could have delayed a launch for years.

The FDA is reviewing the drug under a priority timetable reserved for groundbreaking therapies. A decision is expected by late September.

About 2.5 million people worldwide have multiple sclerosis. In the most common form of the disease, patients experience periods of well-being followed by periodic relapses.

Shares of Novartis rose $1.52, or 3.3 percent, Thursday to close at $47.45.