The U.S. FDA approval won in June by Argenx SE of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) sparked interest in other prospects taking aim at the rare disease. Some – including Argenx – are going after generalized myasthenia gravis and multifocal motor neuropathy with their compounds.
Argenx SE gained U.S. FDA approval of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The company’s stock (NASDAQ:ARGX) was up 11.7% to $440.59 at the close of trading June 24. About 24,000 people in the U.S. are being treated for CIDP, and patients are generally diagnosed between 40 and 60 years of age.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
Argenx SE’s surprise phase III blowup with subcutaneous Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in the platelet disorder primary immune thrombocytopenia (ITP) – blamed on a higher-than-expected placebo response – had investors speculating about possible read-throughs to other indications.
The picture keeps getting brighter for Argenx SE which, having targeted $750 million in a financing after positive phase II data, priced a global public offering of $1.1 billion, one of history’s larger rounds. Amsterdam-based Argenx capitalized on positive top-line data from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy.
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc.
Adults with generalized myasthenia gravis (gMG) have yet another therapeutic option, this time from UCB SA, with the U.S. FDA’s approval of orphan drug Rystiggo (rozanolixizumab-noli), a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor.
