Argenx NV’s Vyvgart (efgartigimod), approved late Friday by the FDA for treating generalized myasthenia gravis, became the first FcRn antagonist to cross the finish line. But the best news may be the drug’s broad label, which company executives highlighted during an investor call.
Harbour Biomed Therapeutics Ltd. said its anti-FcRn monoclonal antibody, batoclimab, generated top-line phase II data in generalized myasthenia gravis, and the company expects to move into a phase III study by the end of this year, with final data reported in April 2022.
Strong top-line results from Immunovant Inc.’s phase IIa clinical trial of IMVT-1401 in treating moderate to severe generalized myasthenia gravis increased the competition with Momenta Pharmaceuticals Inc. and Argenx SE in the crowded anti-FcRn space.
Argenx SE’s later-stage effort with antibody fragment efgartigimod in generalized myasthenia gravis (gMG) was designed with guidance from the phase II trial that showed 75% of patients had a durable response of at least six weeks.
New York-based Immunovant Inc.’s phase IIa results with neonatal Fc receptor (FcRn)-targeting IMVT-1401 in thyroid eye disease (TED), also known as Graves’ ophthalmopathy, prompted renewed speculation about the space, hot since the approval on Jan. 21 of Tepezza (teprotumumab-trbw) from Horizon Therapeutics plc, of Dublin.
