FDA Approves Qfitlia (fitusiran) for Hemophilia A and B – The Babak Lab
The Babak Lab shared a post on LinkedIn:
“Clinical Mondays: FDA Approves Qfitlia (fitusiran) for Hemophilia A and B.
The FDA has just approved Qfitlia (fitusiran), a novel treatment for hemophilia A or B in patients 12 years and older, with or without factor inhibitors. This therapy offers a less frequent dosing option, administered subcutaneously up to once every two months, a major advancement for patients managing this lifelong condition.
How it works: Unlike traditional factor replacements, Qfitlia reduces antithrombin levels, boosting thrombin production to improve clotting. Dosing is personalized using the INNOVANCE Antithrombin companion diagnostic, ensuring optimal efficacy and safety.
In clinical trials, Qfitlia demonstrated:
- 73% reduction in annual bleeding rates for patients with inhibitors.
- 71% reduction for patients without inhibitors.
However, Qfitlia carries a warning for thrombotic events and gallbladder disease, along with liver toxicity monitoring requirements.
Nonetheless, the FDA has granted Qfilia “Orphan Drug” and “Fast Track” designations, reducing treatment burden while improving the quality of life of patients with this rare disease.”
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