Biogen application for subcutaneous Tysabri rejected

 Biogen Inc. (Nasdaq: BIIB) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its supplemental Biologic License Application (sBLA) for a new subcutaneous (SC) route of administration of TYSABRI® (natalizumab) to treat relapsing multiple sclerosis (MS). The CRL indicates that the FDA is unable to approve the Company’s filing as submitted. Biogen is evaluating the CRL and will determine next steps in the U.S.

“We are committed to MS and pursuing innovations such as new routes of administration to help provide options that could address the individual needs of patients,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “This response from the FDA does not affect the intravenous administration of TYSABRI, a well-established high-efficacy treatment with a well-characterized safety profile, which over the last 15 years has treated more than 200,000 people worldwide with relapsing MS.”

The subcutaneous delivery of TYSABRI was approved by the European Commission in March 2021, and Biogen plans to pursue regulatory filings in additional countries.

https://www.biospace.com/article/releases/biogen-provides-regulatory-update-on-the-supplemental-biologic-license-application-sbla-for-subcutaneous-administration-of-tysabri-natalizumab-/