Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

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👉“Ianalumab has potential to become first targeted treatment for this autoimmune disease with significant unmet need”
#Sjogren #Ianalumab

Investigational Drug Ianalumab Enhances ITP Treatment Efficacy Compared to Placebo Ianalumab, a first-in-class drug combined with standard therapy, significantly improves treatment outcomes for immune thrombocytopenia patients.

Investigational Drug Ianalumab Enhances ITP Treatment Efficacy Compared to Placebo #無し #Novartis #ITP #Ianalumab

Sjögren-Syndrom: Gleich zwei erste spezifische Arzneistoffe in Sicht Das Sjögren-Syndrom ist vor allem durch Mund- und Augentrockenheit gekennzeichnet; systemische Manifestationen sind möglich. Nun könnte demn...

Das #Sjögren-Syndrom ist vor allem durch Mund- und Augentrockenheit gekennzeichnet; systemische Manifestationen sind möglich. Nun könnten demnächst erstmals spezifisch zugelassene Medikamente auf den Markt kommen. Für #Telitacicept und #Ianalumab wurden nun Phase-III-Daten präsentiert.

#Ianalumab met its Phase 3 clinical trial primary end points in #Sjogrens. Up to 10% of patients in the clinical trials had seronegative Sjogren's (anti-SSA negative)!

It is on a fast track at the FDA. Let's hope Kennedy doesn't insist that Sjogren's can be cured by just eating better.

Novartis shares slightly up after Ianalumab meets goals in Phase 3 trial Investing.com -- Novartis (NYSE:NVS) (SIX:NOVN) said its experimental antibody ianalumab, used in combination with eltrombopag, achieved the main goal in a phase 3 (VAYHIT2) study for patients with primary immune thrombocytopenia (ITP). The treatment significantly extended the time to treatment failure, measuring how long patients maintained safe platelet levels during and after therapy. Novartis shares climbed 0.5% in European trading. The Swiss drugmaker said the late-stage trial involved ITP patients who had previously received corticosteroids, and showed that ianalumab also prolonged the duration of safe platelet counts beyond the treatment period. ITP is a rare autoimmune condition in which the immune system destroys platelets, the blood cells needed for clotting. A key secondary endpoint was also met, with patients showing a notably higher rate of sustained platelet count improvements, according to Novartis. The company plans to present the results at an upcoming medical conference and include the data in regulatory submissions targeted for 2027. “While current treatments for ITP are generally effective in raising platelet counts, many patients require life-long treatment to maintain safe levels, which can create a lasting treatment burden,” said Adam Cuker, Professor of Medicine and Chief, Section of Hematology, University of Pennsylvania. “The results from VAYHIT2 are encouraging, as they suggest that ianalumab may support longer periods of disease control and reduce the need for continuous treatment.” Ianalumab is being studied as a potential therapy for multiple autoimmune diseases. On Monday, Novartis reported that the drug also met primary endpoints in two phase 3 trials in Sjoegren’s disease. The drug has been granted fast track status by the U.S. Food and Drug Administration, and Novartis said it will seek approval from regulators worldwide. If cleared, ianalumab could become the first targeted therapy for patients with Sjoegren’s disease. "Overall, we believe that the detailed data is needed to fully assess the strength of the efficacy benefit seen,” said Jefferies analysts in a note. Don't miss out on the next big opportunity! Stay ahead of the curve with ProPicks AI – 6 model portfolios fueled by AI stock picks with a stellar performance this year... In 2024 alone, ProPicks AI identified 2 stocks that surged over 150%, 4 additional stocks that leaped over 30%, and 3 more that climbed over 25%. That's an impressive track record. With portfolios tailored for Dow stocks, S&P stocks, Tech Stocks, and Mid Cap stocks, you can explore various wealth-building strategies. So if NOVN is on your watchlist, it could be very wise to know whether or not it made the ProPicks AI lists.

Click Subscribe #Novartis #Ianalumab #Phase3Trial #ClinicalTrials #Investing

😍 How exciting! #Ianalumab by @Novartis , the first every drug to pass phase 3 trials for @Sjogrens! Could we have our very first FDA-approved drug to treat the systemic manifestations of Sjogren's?
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I can't wait to offer my patients the potential for relief!

Novartis Achieves Landmark Progress in Sjögren's Disease Treatment with Ianalumab Trials Novartis celebrates a significant breakthrough with ianalumab in Phase III trials for Sjögren's disease, providing hope for effective targeted treatment options.

Novartis Achieves Landmark Progress in Sjögren's Disease Treatment with Ianalumab Trials #United_States #Novartis #East_Hanover #Sjögren's_Disease #Ianalumab