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FDA grants priority review to Genentech's Enspryng for rare disease MOGAD

Thu, 10 Sep 2026 01:11:18 -0400

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration has granted Priority Review to a supplemental Biologics License Application for Enspryng (satralizumab) as a treatment for myelin oligodendrocyte glycoprotein antibody-associated disease, known as MOGAD. The FDA is expected to make an approval decision by January 10, 2027.

The application is based on results from the Phase III METEOROID study, which showed Enspryng reduced the risk of a new relapse by 68% compared to placebo (p=0.0025). In the trial, 87% of Enspryng-treated patients remained relapse-free at 48 weeks, compared to 67%

FDA grants priority review to Genentech's Enspryng for rare disease MOGAD

Thu, 10 Sep 2026 01:11:18 -0400

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

Thu, 10 Sep 2026 01:11:00 -0400

If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease)
Filing acceptance is based on the Phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68%
MOGAD is a rare disease of the central nervous system characterized by unpredictable attacks of the optic nerves, spinal cord or brain

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for

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

Thu, 10 Sep 2026 01:11:00 -0400

If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease)
Filing acceptance is based on the Phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68%
MOGAD is a rare disease of the central nervous system characterized by unpredictable attacks of the optic nerves, spinal cord or brain

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

Thu, 10 Sep 2026 01:11:00 -0400

If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease)
Filing acceptance is based on the Phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68%
MOGAD is a rare disease of the central nervous system characterized by unpredictable attacks of the optic nerves, spinal cord or brain

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

Thu, 10 Sep 2026 01:11:00 -0400

If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease)
Filing acceptance is based on the Phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68%
MOGAD is a rare disease of the central nervous system characterized by unpredictable attacks of the optic nerves, spinal cord or brain

Roche gets FDA clearance for two new laboratory analytical units

Mon, 30 Mar 2026 09:01:32 -0400