Iryna Drozd
Argenx (NASDAQ:ARGX) said that the U.S. Food and Drug Administration (FDA) extended the review of its application seeking approval of subcutaneous (SC) efgartigimod to treat adult patients with generalized myasthenia gravis (gMG), to June 20.
The company had filed a biologics license application (BLA) for SC efgartigimod (1000mg efgartigimod-PH20) in September 2022. The BLA was backed by data from a phase 3 trial called ADAPT-SC.
The FDA said that the information submitted in connection with the ongoing review of the SC efgartigimod BLA was a major amendment and required an extension to allow more time to review, the Netherlands-based company said in a press release on Friday.
Argenx noted that no additional data or studies were requested at this time.
“We are confident in the profile of SC efgartigimod and the strength of the ADAPT-SC dataset showing noninferiority of our subcutaneous product to VYVGART,” said argenx’s Chief Medical Officer Luc Truyen.
SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s (HALO) drug delivery technology ENHANZE.
Myasthenia gravis is an autoimmune neuromuscular disorder mainly characterized by muscle weakness and muscle fatigue which can make it difficult to chew, swallow, stand and walk, among other things.
ARGX -2.04% to $374.29 premarket Jan. 27
