Label expansion for Ultomiris under review by US FDA

AstraZeneca (LSE: AZN) has announced that a supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis (gMG) has been accepted for Priority Review by the US Food and Drug Administration.

The agency is due to make a decision in the second quarter of 2022, after the firm made use of a coveted priority review voucher held by its newly-acquired rare diseases company, Alexion.

The therapy has been shown in late-stage trials to be effective in the treatment of the debilitating disease, a chronic autoimmune disorder which can undermine muscle function and cause severe weakness.