First Oral MS Drug Gets FDA Panel's Blessing

THURSDAY June 10, 2010 -- An expert advisory panel of the U.S. Food and Drug Administration on Thursday recommended that the agency approve an oral drug, Gilenia, as a first-line treatment for multiple sclerosis (MS).

Gilenia appears to be both safe and effective, the panel confirmed in two separate votes.

Approval would mark a major shift in MS therapy since other drugs for the neurodegenerative illness require frequent injections or intravenous infusions.

"This is revolutionary," said Dr. Janice Maldonado, an assistant professor of neurology at the University of Miami Miller School of Medicine. "It's a marvelous achievement of being the first oral drug out for relapsing multiple sclerosis."

Maldonado, who has participated in trials with the drug, said the results have been very encouraging. "All of our patients have done well and have not had any problems, so it's quite promising," she said.

Patricia O'Looney, vice president of biomedical research at the National Multiple Sclerosis Society, went even further, saying that "this is a historic day. The panel recommended the approval of Gilenia as a first-line option for people with MS."

As an oral drug, it opens the door to more MS sufferers accepting treatment, she explained. "Those people who have not been on therapy, for a variety of reasons, because they did not like the injections, didn't like the infusions or they are not on therapy because they didn't respond to the other drugs -- this is another option."

In its first vote of the day, the FDA panel voted 25-0 that the drug was effective in reducing relapses of multiple sclerosis, which causes a host of movement and cognitive problems, according to the Associated Press.

But because side effects of the drug are a concern, the panel voted that Novartis, the maker of Gilenia, conduct tests to see if the drug is effective at lower doses, the AP reported. However, the panel said that these tests could be conducted after the drug reaches the market. Requiring such a study before approval could have kept the drug off the market for years.

Currently, the FDA is reviewing the drug as a priority, which is reserved for groundbreaking therapies. A decision is expected by late September, according to the AP.

A study of 1,200 patients conducted by Novartis showed about a 30 percent reduction in the relapse rate among patients taking the Gilenia compared to older drugs, such as Bayer's Betaseron and Biogen Idec's Avonex, the news service noted.

However, the agency is concerned about serious side effects that occurred in about 8.5 percent of patients taking Gilenia, compared with 5.8 percent of patients taking older MS drugs, the AP reported. Those side effects can include heart and lung problems, and eye disorders.

Although the FDA is not required to follow the panel's recommendation, it usually does.

Around the world, about 2.5 million people suffer from MS, which can cause muscle tremors, paralysis and problems with speech, memory and concentration. In the most common form of the disease, patients experience periods with no symptoms followed by periodic relapses.

More information

For more on MS, visit the National Multiple Sclerosis Society.

Posted: June 2010


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