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Enspryng FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved August 14, 2020)
Brand name: Enspryng
Generic name: satralizumab-mwge
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Neuromyelitis Optica Spectrum Disorder

Enspryng (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Development Timeline for Enspryng

DateArticle
Aug 14, 2020Approval  FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder
May 21, 2020New Longer-Term Data Reinforce Safety of Genentech’s Satralizumab in Adults and Adolescents With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Dec  1, 2019Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine
Oct 29, 2019FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder
Sep  3, 2019Genentech to Present Pivotal Data for Satralizumab in Neuromyelitis Optica Spectrum Disorder

Further information

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