FDA Puts Biogen MS Drug on Fast Track to Approval

A new multiple sclerosis medication being developed by Biogen Idec has earned expedited-review status at the Food and Drug Administration because authorities say the drug may treat the disease better than currently available medications.

The drug, called PEGylated interferon beta-1a, is a shot designed to be taken once or twice a month as opposed to weekly shots required for most MS drugs.

“Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis,” said Dr. Michael Panzara, vice president and chief medical officer of neurology at Biogen Idec, according to a report in the Boston Business Journal. “We look forward to working closely with the FDA to expedite the compound’s development and review process.”

Biogen is now assembling participants for a late-stage clinical trial of the drug. The company says it plans to include at least 1,200 patients in that study to determine how effective PEGylated interferon beta-1a is in preventing relapses of MS in patients.

Other MS Drugs Garner Controversy

Biogen already has two MS drugs on the market – Tysabri and Avonex.

Tysabri has been very controversial since its launch in 2004 due to some patients developing a potentially deadly brain infection called progressive multifocal leukoencephalopathy (PML). At least 10 Tysabri users have developed PML, including two patients who died.

In April, federal product safety officials to exception to some on-line ads for Tysabri, which they said gave inaccurate and incomplete information about the risks of the drug. Tysabri also has been associated with liver damage and melanoma in some users.

Some studies have shown that Avonex is not as effective as other drugs at preventing MS relapses and can produce more adverse reactions, including lesions.

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