Pfizer's Hympavzi Receives EU Approval, Novartis Raises Sales Outlook
核心洞察
The European Commission has approved Pfizer's Hympavzi (marstacimab) for hemophilia A (搜索) and B treatment, based on positive Phase III BASIS study data.
Novartis has increased its mid-term sales growth guidance, projecting a 5% CAGR for 2024-2029, driven by key drugs and pipeline candidates.
Lilly (搜索)'s muvalaplin demonstrated significant reduction in lipoprotein(a) levels in a Phase II study, showing promise for cardiovascular risk reduction.
The European Commission has granted marketing authorization to Pfizer’s Hympavzi (marstacimab), an anti-TFPI inhibitor, for the treatment of hemophilia A (搜索) and B. This approval, based on positive Phase III BASIS study data, allows Hympavzi to be used as a prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults and adolescents with hemophilia A or B without inhibitors. The FDA approved Hympavzi last month.
This marks Pfizer’s second hemophilia treatment approval this year, following Beqvez/Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for hemophilia B (搜索), which was approved by the FDA in April 2024 and is currently under review in the EU.
Novartis Ups Sales Forecast
Novartis has raised its mid-term sales growth guidance, increasing the CAGR target for the 2023-2028 period from 5% to 6%. Projecting forward from 2024, Novartis anticipates a 5% CAGR for sales between 2024 and 2029. This optimistic outlook is supported by strong sales expectations for key drugs such as Pluvicto, Kesimpta, Kisqali, Cosentyx, and Leqvio, along with several upcoming launches. Novartis reports that eight of its drugs have peak sales potential between $3 billion and $8 billion, and its pipeline includes 30 candidates expected to sustain mid-single-digit sales growth beyond 2029. The company remains on track to achieve a core operating income margin of over 40% by 2027.
Lilly's Muvalaplin Shows Promise
Eli Lilly (搜索) and Company announced positive results from a Phase II study of its oral, once-daily cholesterol-lowering candidate, muvalaplin. The study demonstrated that muvalaplin significantly reduced lipoprotein(a) or Lp(a) levels in adults at high risk of cardiovascular events (搜索) over a 12-week period. The highest dose (240 mg) of muvalaplin reduced Lp(a) levels by 85.8% using an intact Lp(a) assay, meeting the study’s primary endpoint of percent change in Lp(a) from baseline to week 12. Muvalaplin also met secondary endpoints for all three doses tested. Muvalaplin features a novel mechanism of action, disrupting the interaction between apolipoprotein(a) and apolipoprotein(b), thereby preventing the formation of Lp(a), a key component that elevates cardiovascular risk.