BRIEF—FDA extends PDUFA date for SC efgartigimod

Belgo-Dutch immunology company argenx saw its shares close down 1.4% at 345.80 eurostoday, after it revealed that the US Food and Drug Administration (FDA) has extended the review of the Biologics License Application (BLA) for subcutaneous (SC) efgartigimod (1,000mg efgartigimod-PH20) for the treatment of adult patients with generalized myasthenia gravis (gMG) to June 20, 2023.

The FDA notified argenx on January 26, 2023 that information submitted in connection with the ongoing review of the SC efgartigimod BLA constituted a major amendment and requires an extension to allow sufficient time to review. No additional data or studies have been requested at this time.

“We are confident in the profile of SC efgartigimod and the strength of the ADAPT-SC dataset showing non-inferiority of our subcutaneous product to Vyvgart. We will continue to work closely with the FDA as it completes its review to bring this important medicine to people living with gMG," said Dr Luc Truyen, chief medical officer of argenx.

Vyvgart is already approved as an intravenous injection.