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, concentration problems and other symptoms of the debilitating disease.
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Swiss drugmaker Novartis has asked the Food and Drug Administration to approve its drug Gilenia as the first pill for multiple sclerosis. All of the existing drugs require frequent injections or infusions, and some can cause flu-like side effects.
Doctors say more tolerable therapies are needed to treat multiple sclerosis.
The Food and Drug Administration's panel of nervous system experts 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 the proposed dose of the drug appears safe.
Despite that overwhelming endorsement of the drug, panelists had questions about side effects with the drug, including eye disorders, heart problems and weakened lung function.
Those side effects were less common when patients received the lower of two doses tested by Novartis. But panelists questioned whether an even lower dose might be safer while still benefiting patients.
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 does, 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.
A one-year study of 1,200 patients conducted by Novartis showed about a 30 percent reduction in relapse rate in patients taking the pill rather than older interferon drugs, such as Bayer's Betaseron and Biogen Idec's Avonex.
But the FDA is concerned about frequent serious side effects that occurred in at least 8.5 percent of patients taking Novartis' drug, compared with 5.8 percent of patients taking older multiple sclerosis drugs.
About 2.5 million people worldwide 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.
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