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CSL Seeks Disruption Of HAE Space With Monthly Prevention Product

 
• By Joseph Haas

Based on top-line Phase III data for garadacimab, CSL is preparing to submit the Factor XIIa inhibitor for US FDA approval for monthly prophylaxis of hereditary angioedema and expand the firm’s HAE franchise.

CSL heaquarters
CSL is planning to add a third HAE product to its portfolio • Source: Shutterstock

With positive top-line data for garadacimab from the Phase III VANGUARD study, CSL Limited is ready to expand its hereditary angioedema franchise with a Factor XIIa inhibitor that could offer monthly prophylaxis against the disease. While it could cannibalize from the rest of its HAE franchise, the specialty pharma told its 17 August fiscal year 2022 earnings call it hopes to disrupt the HAE space now that it has positive Phase III data for garadacimab.

Focused largely on blood plasma-derived therapies, the Australian firm is working its way through COVID-19 pandemic-related supply chain issues but has continued to see growth for its two-drug hereditary angioedema...

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