Juvisé Acquires Multiple Sclerosis Drug PONVORY and also Opens Its Capital
Vanda Pharmaceuticals Announces a U.S. Patent Allowance for PONVORY
J&J unloads certain Ponvory rights to Vanda for $100M
WASHINGTON, Dec. 7, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has acquired U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. PONVORY® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. PONVORY® has a proven safety profile with over 10 years of data.
NICE has issued a positive Final Appraisal Document (FAD) recommending PONVORY® (ponesimod) as an option in England and Wales for the treatment of relapsing-remitting multiple sclerosis (RRMS). The once-daily oral treatment has been approved for adults with active disease defined by clinical or imaging features. RRMS is the most common form of MS, where attackes (relapses) are followed by periods of partial or complete recovery.
Janssen has announced that the Scottish Medicines Consortium (SMC) have accepted Ponvory (ponesimod) within NHS Scotland, as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS). MS currently affects over 15,000 people in Scotland.
BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from a new subgroup analysis of the pivotal Phase 3 OPTIMUM trial. Featured as an e-poster at the 37th Congress of the European Committee for Treatment Research in Multiple Sclerosis (ECTRIMS) from October 13-15, the subgroup analysis showed that in the expanded disability status scale (EDSS) ? 3 subgroup, ponesimod significantly reduced annualised relapse rate (ARR) by 47 percent (rate ratio [RR] = 0.53; 99 percent confidence levels [CLs]: 0.372, 0.755; p<0.0001) and MS-fatigue was statistically significantly lower in the ponesimod group compared with the teriflunomide group at week 108, with a mean difference (MD) of -4.31 (95 percent CLs: -6.99, -1.63; p=0.0017).1,2
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorisation in Great Britain for PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS).
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorisation in Great Britain for PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS).
BEERSE, Belgium--(BUSINESS WIRE)--Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that the European Commission (EC) has approved PONVORY ? (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.4