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Ponvory FDA Approval History

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.

  • Ponvory is thought to work by keeping lymphocytes out of the blood by trapping them in the lymph nodes. It may work in MS by reducing lymphocyte migration into the central nervous system.
  • Ponvory is taken orally once daily, with gradual titration to a maintenance dose.
  • Common adverse reactions include upper respiratory tract infection, hepatic transaminase elevation, and hypertension.

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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