Efmoroctocog alfa(Sobi Analytics)

Sanofi posted a strong set of first-quarter results Thursday morning, with its recombinant factor drug Altuviiio on track to become a blockbuster drug and its crown jewel Dupixent continuing to draw sales. Sales of the French drugmaker’s hemophilia A treatment Altuviiio doubled in the first quarter to €251 million ($286 million), according to a company earnings report . Almost 90% of that number was driven by the US, where patients continued to switch over from older plasma-derived and recombinant factor medicines. The remaining €33 million came from other markets, boosted by a recent launch in Japan. Altuviiio has been steadily gaining market share since it secured FDA approval in 2023, according to Sanofi. If it can replicate its Q1 sales for the rest of the year, the product should reach blockbuster status in 2025, a company spokesperson told Endpoints News in an email. Altuviiio is administered weekly, giving it a significant convenience edge over older recombinant factor drugs, which can require up to thrice weekly dosing. Sanofi’s older recombinant factor medicine, Eloctate, saw sales drop around 21% to €70 million as patients switched to Altuviiio. But its broader hemophilia A franchise fared positively, with sales rising by 50% to €321 million. That number formed part of Sanofi’s total first-quarter sales of €9.9 billion, which were up almost 10% from the same time last year. The figure came in 3% ahead of Wall Street consensus forecasts and was driven by continued growth of the company’s blockbuster inflammatory disease drug Dupixent, Jefferies analysts said in a Thursday note. Dupixent sales were up around 20% in the quarter to €3.5 billion. The growth was driven by rising use in all established indications, as well as “emerging use” in its latest approval for chronic obstructive pulmonary disorder, Sanofi said. Dupixent is expected to reach peak sales of $3.3 billion in COPD alone, according to Wall Street consensus estimates. Sanofi’s hemophilia offering was further bolstered by an FDA approval for siRNA medicine Qfitlia in hemophilia A and B last month. Qfitlia will be sold in the US at an average cost of $642,000 per year, but comes with a boxed warning for thrombotic events and gallbladder disease. Sanofi also reported a Phase 2 disappointment for its oral TNF inhibitor, balinatunfib, in psoriasis. The drug did not hit statistical significance in the primary endpoint of PASI-75, which measures the proportion of patients with a minimum 75% improvement in their psoriasis area and severity index score. Sanofi said the failure was driven by “the limited nature” of the trial, adding it would share full data at a future medical meeting. For now, the company is considering potential combination approaches for balinatunfib. Elsewhere, Sanofi made several cuts to its cancer pipeline. The drugmaker terminated a Phase 2 trial for NK cell engager SAR443579 in acute myeloid leukemia and a Phase 1 study of monoclonal antibody SAR444881 in solid tumors. The cuts are part of a broader pipeline prioritization that should help the company focus on its goal of becoming a world leader in immunology, the spokesperson said. On a call with the media on Thursday, CFO François Roger said the company is continuing to assess how the looming pharma tariffs would impact its business. Editor’s Note: This article was updated to add information about the balinatunfib trial failure and the company’s comments on potential pharma tariffs.

STOCKHOLM, April 23, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) presents clinical data aimed at updating the global haemophilia community attending this year's WFH 2025 Comprehensive Care Summit in Dubai from the 23 – 25 April. New and updated outcomes and analyses will be presented from the XTEND phase 3clinical program testing the effectiveness of Altuvoct® (efanesoctocog alfa) treatment for haemophilia A, including updates on patients' joint health and surgical outcomes in patients. "At WFH 2025 CCS, Sobi will present highlights from the XTEND phase 3 program and discuss the new treatment paradigm with FVIII levels in the non-haemophilia range. Sharing these clinical outcomes with the wider haemophilia community will help to ensure the latest treatment approaches are widely known and understood," said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA), and Chief Medical Officer at Sobi. Key data to be presented at WFH 2025 Comprehensive Care Summit, Dubai, UAE Altuvoct® (efanesoctocog alfa) About efanesoctocog alfa Efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] (formerly BIVV001) is a novel and significant part of the week factor VIII therapy. It has the potential to deliver near-normal factor activity levels for significant parts of the week, improving bleed protection in a once-weekly dose for people with haemophilia A. Efanesoctocog alfa builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN® polypeptides to extend its time in circulation. It is the only therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. It was approved as ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] by Sanofi in the US in February 2023. About the Sobi and Sanofi collaboration Sobi and Sanofi collaborate on the development and commercialisation of Alprolix® and Elocta®/Eloctate®. The companies also collaborate on the development and commercialisation of efanesoctocog alfa, referred to as ALTUVIIIO™ in the USA and ALTOVUCT in Europe. An investigational factor VIII therapy with the potential to provide high sustained factor activity levels with once-weekly dosing for people with haemophilia A. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory. Sobi® Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East and Asia. In 2022, revenue amounted to SEK 18.8 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Contact For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED