27 January 2023 - argenx today announced that the US FDA has extended the review of the biologics license application for subcutaneous efgartigimod (1000 mg efgartigimod-PH20) for the treatment of adult patients with generalised myasthenia gravis to 20 June 2023.

The FDA notified argenx on 26 January 2023 that information submitted in connection with the ongoing review of the subcutaneous efgartigimod biologics license application 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.

Read argenx press release