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U.S. FDA Grants Priority Review for Genentech’s Enspryng for MOGAD, an Autoimmune Disease With No Approved Treatments

RHHBY
  • The FDA granted Priority Review to Genentech's supplemental Biologics License Application for Enspryng (satralizumab) to treat myelin oligendrocyte glycoprotein antibody-associated disease (MOGAD).
  • Enspryng would be the first & only disease-modifying therapy approved for MOGAD if the application is accepted.
  • The filing is based on the Phase III METEOROID study, which showed Enspryng reduced the risk of relapses by 68% compared to placebo.
  • In the METEOROID study, 87% of patients treated with Enspryng remained relapse-free at 48 weeks versus 67% in the placebo arm.
  • The FDA expects to make a decision on the MOGAD approval by January 10, 2027.
  • The European Medicines Agency has validated the application for Enspryng for MOGAD in Europe, with a decision expected in the third quarter of 2027.
  • MOGAD is a rare autoimmune disease of the central nervous system characterized by unpredictable attacks on the optic nerves, brain, or spinal cord.
  • Currently, there are no approved treatment options available for MOGAD.
  • Enspryng is an IL-6 inhibitor developed by Chugai & is already approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD).
  • The safety profile in the METEOROID study was consistent with data from over a decade of Enspryng clinical trials & post-approval experience.
  • Common side effects of Enspryng include sore throat, runny nose, rash, fatigue, extremity pain, headache, upper respiratory tract infections, nausea, gastritis, & joint pain.
  • Serious side effects may include infections, increased liver enzymes, low neutrophil counts, & serious allergic reactions.
  • Patients with active hepatitis B, active tuberculosis, or latent tuberculosis should not receive Enspryng.