BRIEF—UCB's zilucoplan closer to market in USA and Europe

Belgian biopharma UCB has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application for zilucoplan.

This investigational treatment is a subcutaneous, self-administered C5 inhibitor for the treatment of adults with acetylcholine receptor antibody positive (AChR-Ab+) generalized myasthenia gravis (gMG).

The FDA acceptance follows the recent European Medicines Agency (EMA) validation of the Marketing Authorization Application (MAA) for zilucoplan for the treatment of adults with AChR-Ab+ gMG and who require treatment in addition to steroids or non-steroidal immunosuppressants.

The EMA validation confirms that the application is complete and the formal review process by the agency’s Committee for Medicinal Products for Human Use can begin.

UCB anticipates making regulatory filings for zilucoplan in gMG in the UK, Japan and the rest of the world imminently.