UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review

UCB

6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment of adults with myasthenia gravis who are anti-acetycholine receptor or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

UCB today announced that the US FDA has accepted the company’s filing to review a biologic license application for its investigational treatment rozanolixizumab, and that the Agency has granted priority review.

Read UCB press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier