Argenx's Ambitious Plans For Efgartigimod On Track

As Europe's regulators start their review of efgartigimod for generalized myasthenia gravis (gMG), argenx N.V. has been beefing up its commercial operations while expanding the number of indications planned for the Belgian-Dutch biotech's pipeline-in-a-product opportunity.

The company has announced that the European Medicines Agency has validated the marketing authorization application for the FcRn antagonist as a treatment for gMG, a rare autoimmune disease where muscles throughout the body may be affected, resulting in extreme fatigue and difficulties with facial expression, speech, swallowing and mobility. Argenx's request to get an accelerated assessment from the agency was rejected so a decision is now expected mid-2022. If approved, efgartigimod would go up against AstraZeneca PLC unit Alexion's blockbuster C5 inhibitor Soliris (eculizumab) in gMG and the follow-on product Ultomiris (ravulizumab)