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Ponvory FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2021.

FDA Approved: Yes (First approved March 18, 2021)
Brand name: Ponvory
Generic name: ponesimod
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Sclerosis

Ponvory (ponesimod) is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Development timeline for Ponvory

DateArticle
Mar 19, 2021Approval FDA Approves Ponvory (ponesimod) for the Treatment of Adults with Relapsing Multiple Sclerosis
Mar 18, 2020Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis
Jul 25, 2019Janssen Reports Positive Top-Line Phase 3 results for Ponesimod in Adults with Relapsing Multiple Sclerosis

Further information

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