Neurological

The FDA is denying Tysabri approval for subcutaneous administration

The Food and Drug Administration (FDA) has issued Biogen a Complete Response Letter (CRL) regarding the Supplementary Biologics License Application (sBLA) for the subcutaneous (SC) administration of Tysabri® (natalizumab).

Tysabri, an integrin receptor antagonist, is approved as monotherapy for the treatment of relapsed forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adults. As there is an increased risk of progressive multifocal leukoencephalopathy, it should be assessed prior to starting treatment to determine whether the drug’s benefits are sufficient to offset this risk.

Currently, the FDA-cleared route of administration of Tysabri for MS is by intravenous infusion. In the CRL, the Agency noted that the application for the new SC management path could not be approved in its current form.

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“This FDA response does not affect intravenous administration of Tysabri, an established, highly effective treatment with a well-characterized safety profile that has treated more than 200,000 people with relapsed MS worldwide over the past 15 years,” said Maha Radhakrishnan, MD, Chief Medical Officer at Biogen.

In a statement, Biogen stated that the CRL is being evaluated to determine the next steps. The company recently received approval from the European Commission to market Tysabri’s SC injection and is planning further regulatory filings in other countries.

reference

Biogen offers a regulatory update to the supplementary Biologics License Application (sBLA) for the subcutaneous administration of Tysabri® (natalizumab). [press release]. Cambridge, MA: Biogen Inc; April 28, 2021.

This article originally appeared on MPR

Subjects:

Multiple Sclerosis Treatments

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