argenx: FDA Accepts Filing for Efgartigimod for Myasthenia Gravis

 

• If approved, efgartigimod will be the first-and-only approval of an FcRn antagonist
• Prescription Drug User Fee Act (PDUFA) target action date is December 17, 2021
• Pre-approval access program opened in U.S. for efgartigimod for eligible people living with gMG

https://www.globenewswire.com/news-release/2021/03/02/2184873/0/en/argenx-Announces-FDA-Acceptance-of-BLA-Filing-for-Efgartigimod-for-the-Treatment-of-Generalized-Myasthenia-Gravis.html