FDA Approves New Option for Generalized Myasthenia Gravis

The FDA recently expanded the approval of Soliris (eculizumab) to include adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive.

Soliris was originally approved by the FDA for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It works by inhibiting the terminal part of the complement cascade, which plays a role in the pathology of rare disorders such as anti-AchR antibody-positive gMG, PNH, and aHUS.
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Approval for the new indication was based on data from the Phase 3 REGAIN trial and an ongoing open-label extension study. In the trial, Soliris demonstrated treatment benefits among patients with anti-AchR antibody-positive gMG who experienced prior treatment failure and continued to experience significant unresolved symptoms.

Common adverse effects associated with Soliris among patients with anti-AchR antibody-positive gMG include musculoskeletal pain and an increased risk for infections.

In addition, Soliris has a boxed warning of the risk for serious meningococcal infections. Patients are recommended to receive meningococcal vaccination at least 2 weeks prior to initiating treatment unless the risks of delaying treatment are greater than the risk of developing the infection. Health care providers should monitor patients for early signs of meningococcal infections and immediately evaluate patients if they are suspected to have the infection. 

—Melissa Weiss

Reference:

FDA approves Soliris® (Eculizumab) for the treatment of patients with generalized myasthenia gravis (gMG) [press release]. New Haven, CO: Alexion, October 23, 2017. http://news.alexionpharma.com/press-release/product-news/fda-approves-soliris-eculizumab-treatment-patients-generalized-myasthenia.