The FDA is making argenx wait on an approval decision for subcutaneous efgartigimod. After receiving more information from argenx, the regulator extended the review and pushed the PDUFA date back to the summer.
Late last year, the FDA accepted an application for approval of the candidate, a subcutaneous version of the antibody fragment in argenx’s intravenous myasthenia gravis (gMG) drug Vyvgart, and set the PDUFA date as March 20. Now, with the finish line in sight, argenx has suffered a setback that could delay its plans to bring the subcutaneous formulation to market.
The change to the timeline follows argenx’s submission of information in connection with the review of the formulation. After deeming the submission to be a major amendment, the FDA changed the PDUFA date to June 20 to give itself time to review the additional information.
Argenx has identified the subcutaneous formulation as one of five ways to increase use of efgartigimod, the others being geographic expansion, a move into earlier-line patients, a filing in Japan and studies in new indications. Luc Truyen, M.D., Ph.D., chief medical officer at argenx, reiterated his belief in the new formulation in a statement to disclose the delay.
“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. We will continue to work closely with the FDA as it completes its review to bring this important medicine to people living with gMG,” Truyen said.
Argenx reported $402 million in preliminary full-year global net Vyvgart sales earlier this month.