Elan and Biogen get FDA fast-track Tysabri review

Multiple sclerosis drug Tysabri has been given a priority review from the US Food and Drug Administration (FDA), according to pharmaceutical companies Elan and Biogen Idec.

A licence application made by the firms for the drug to be used with MS sufferers was approved by the FDA, but the agency also awarded a priority review in recognition that the Tysabri could offer an important treatment to patients with the disease.

A study into the effectiveness of the drug when combined with Avonex, completed earlier in the year, discovered that it slowed down the progression of disability in patients who suffer from relapsing MS.

“We are pleased that TYSABRI has received Priority Review designation, which we believe, reflects the unmet need in MS,” said Burt Adelman of Biogen Idec. “We look forward to working with the FDA throughout the review process and are hopeful that we will be able to bring TYSABRI back to people living with MS.”

Lars Ekman of Elan said that he was pleased with the announcement: “We believe that the acceptance of the sBLA for Priority Review is another step in our ongoing commitment to provide TYSABRI as a treatment option for MS patients in need.”

The drug had earlier been removed from the market, following fears that it could cause progressive multifocal leukoencephalopathy (PML), a rare central nervous system disorder.

A recent safety study cleared the drug, finding no cases of PML among 3,000 patients.

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