Cablivi
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Sanofi (SNY) Secures Approval for Cablivi in the US and Plozasiran in China
Yahoo Finance· 2026-01-16 17:12
Sanofi (NASDAQ:SNY) is one of the best blue-chip stocks to buy for 2026. On January 5, the US Food and Drug Administration announced the approval of Sanofi SA (NASDAQ:SNY)’s Cablivi. The approval covers the use of the injection to treat pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP). Sanofi (SNY) Secures Approval for Cablivi in the US and Plozasiran in China The injection was first approved in 2019 for the treatment of adults with thrombotic thromboc ...
X @The Wall Street Journal
The Wall Street Journal· 2025-12-11 06:46
Two bleeding disorder treatments for both chronic and acute conditions, Qfitlia and Cablivi, have been approved in China. https://t.co/jYTwWsGrU4 ...
Sanofi's Bleeding-Disorder Treatments Get Approval in China
WSJ· 2025-12-11 06:42
Core Insights - Two treatments for bleeding disorders, Qfitlia and Cablivi, have received approval in China [1] Group 1 - Qfitlia is indicated for chronic bleeding disorders [1] - Cablivi is indicated for acute bleeding disorders [1]
Press Release: Sanofi’s Qfitlia and Cablivi approved in China, expanding care for rare diseases
Globenewswire· 2025-12-11 06:00
Core Insights - The National Medical Products Administration (NMPA) in China has approved two innovative Sanofi medicines for rare hematologic diseases: Qfitlia for hemophilia and Cablivi for acquired thrombotic thrombocytopenic purpura (aTTP) [1] - These approvals represent Sanofi's fourth and fifth approvals in China for the year, following Tzield and Sarclisa [1] Qfitlia Overview - Qfitlia is the first antithrombin-lowering therapy for routine prophylaxis in hemophilia patients aged 12 and older, including those with severe hemophilia A or B [2] - The approval is based on ATLAS phase 3 studies showing significant reductions in annualized bleeding rates (ABR) for patients treated with Qfitlia [3] - Qfitlia utilizes small-interfering RNA technology, allowing for low treatment frequency and subcutaneous administration [3][15] - Hemophilia affects over 40,000 individuals in China, highlighting the need for effective treatment options [3] Cablivi Overview - Cablivi is the first targeted therapy for treating aTTP in adults and adolescents aged 12 or older [4] - Approximately 2,700 patients are diagnosed with aTTP annually in China, with a mortality rate of up to 20% despite standard treatments [5] - Cablivi works by inhibiting the interaction between von Willebrand factor and platelets, thus preventing microthrombi formation [5][18] Market Impact - The approvals of Qfitlia and Cablivi expand Sanofi's rare hematology portfolio in China, addressing critical unmet needs in chronic bleeding disorders and acute clotting emergencies [6] - Sanofi's commitment to innovation is emphasized by these approvals, aiming to improve outcomes for patients with rare diseases [7] Clinical Results - Qfitlia demonstrated a 71% reduction in ABR for patients without inhibitors and a 73% reduction for patients with inhibitors compared to traditional treatments [9] - In the open-label extension study, nearly 80% of participants were on a regimen of six injections per year, with 94% achieving target AT levels [17]