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European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma pharmiweb.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmiweb.com Daily Mail and Mail on Sunday newspapers.
d the risk of progression or death by nearly half formed the basis for this important EC approval.
Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients This approval is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. The primary endpoint of IKEMA was progression free survival (PFS). While median PFS, defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination therapy; n=179) had not been reached at the time of the pre-planned interim analysis. Sarclisa combination therapy reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007) versus standard of care Kd alone in patients with MM. ....
Sanofi: European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.
European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma globenewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from globenewswire.com Daily Mail and Mail on Sunday newspapers.
(0) TEPEZZA significantly improved the clinical course of Thyroid Eye Disease (TED) in all patient subgroups, including those with more severe disease at baseline For patients in the follow-up period with data available at 51 weeks after the last dose of TEPEZZA, 67 percent had a proptosis response, 69 percent had a diplopia response and 83 percent had an ophthalmic composite outcome response Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new pooled data from the TEPEZZA (teprotumumab-trbw) Phase 2 and Phase 3 clinical trials are now published in The Lancet Diabetes Endocrinology. The data further reinforce that TEPEZZA significantly improves proptosis (eye bulging) and diplopia (double vision) for TED patients in different subgroups, with most maintaining a long-term response. TEPEZZA the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for TED is a fully human monoclonal antibody (mAb) and a targeted ....