- In April 2025, Johnson & Johnson received FDA approval for IMAAVY (nipocalimab-aahu), a new FcRn blocker designed to treat generalized myasthenia gravis (gMG). This marks the first FcRn inhibitor approved for both anti-acetylcholine receptor (AChR) and anti-muscle-specific kinase (MuSK) antibody-positive patients aged 12 and older. The approval was based on findings from the Vivacity-MG3 Phase 3 trial, which demonstrated significant symptom improvement compared to placebo. IMAAVY™ is expected to be available in May 2025, offering long-lasting disease control and expanding treatment options for gMG patients
- In April 2025, The National Pharmaceutical Regulatory Agency (NPRA) in Malaysia issued a directive requiring all registration holders of statin-containing products to update their local package inserts and consumer medication information leaflets. This update reflects the potential risk of statins inducing or aggravating myasthenia gravis (MG), an autoimmune disorder characterized by muscle weakness and fatigue. The directive applies to 186 registered statin products, including atorvastatin, simvastatin, rosuvastatin, lovastatin, pravastatin, and pitavastatin
- In January 2025, Cartesian Therapeutics, Inc. received FDA approval under the Special Protocol Assessment (SPA) process for its Phase 3 AURORA trial of Descartes-08, an mRNA cell therapy candidate for myasthenia gravis (MG). This agreement confirms that the trial design meets regulatory standards to support a future Biologics License Application (BLA), pending trial results. The randomized, double-blind, placebo-controlled study will evaluate Descartes-08’s efficacy in approximately 100 participants, focusing on MG-ADL score improvements
- In October 2023, UCB received FDA approval for ZILBRYSQ® (zilucoplan), a once-daily subcutaneous C5 complement inhibitor for generalized myasthenia gravis (gMG) in anti-acetylcholine receptor (AChR) antibody-positive adults. This approval followed the Phase 3 RAISE study, which demonstrated statistically significant symptom improvements compared to placebo. With ZILBRYSQ and RYSTIGGO, UCB became the first company to offer two distinct targeted therapies for gMG
- In June 2023, UCB received FDA approval for RYSTIGGO (rozanolixizumab-noli), a subcutaneous monoclonal antibody designed to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. This approval was based on findings from the Phase 3 MycarinG study, which demonstrated statistically significant improvements in daily activities such as breathing, talking, and swallowing. RYSTIGGO® is the first FDA-approved treatment for both AChR and MuSK antibody-positive gMG patients
