FDA Gives Fast Track Approval to Biogen-Idec's MS Drug
Biogen Idec

A new multiple sclerosis medication being developed by Biogen Idec has earned Fast Track designation from the U. S. Food and Drug Administration.

The Fast Track status for drugs is given by the FDA to drugs that treat a serious disease and fill an unmet medical need. This would mean less time taken for the approval and the agency said the expedited process was as the drug may treat the disease better than currently available medications.

The drug, called PEGylated interferon beta-1a, is required to be taken once or twice a month without a loss in efficacy as compared to most current MS drugs which require weekly shots.

Dr. Michael Panzara, vice president and chief medical officer of neurology at Biogen Idec said, "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."

"We look forward to working closely with the FDA to expedite the compound's development and review process."

Biogen is in the process of enrolling patients in a late stage phase III clinical trial on the drug and plans to enroll 1,200 patients in the study to evaluate the drugs effectiveness at preventing MS relapses in patients.

Biogen already has two MS drugs Tysabri and Avonex on the market. Tysabri since its launch in 2004 has been plagued with controversy as at least 10 patients on the drug developed a potentially deadly brain infection called progressive multifocal leukoencephalopathy (PML), including two patients who died. Tysabri also has been associated with liver damage and melanoma in some users.

Avonex, Biogen's blockbuster drug which has generated billions of dollars in sale has its own share of problems with some studies indicating the drug not being as effective as other drugs at preventing MS relapses and producing more adverse reactions, including lesions.

Latest News

Father Shoots Girl’s Laptop, Posts Video on Youtube
Apple Begins Inspection
Researchers Blame Technological Advancements For Kids’ Poor Sleeping Pattern
The Google Motorola Deal Approved By US and EU
Replace Sugary Drinks with Water to Lose Weight
NASA Scientists Develop New Space Testbed
Scientists Expecting Life at Icy Dark and Cold Regions
Mysteries Behind Milky Way Galaxy To Be Unveiled
Scientific Equation behind the Shape of Ponytail Unveiled
Cooma People Encouraged To Donate Blood
Knox Receives Less Dental Care Funding
Massive Fight in Sydney Club