Last Updated on December 31, 2023 by The Health Master
New Delhi: Sanofi’s Altuviiio has gained approval from the U.S. Food and Drug Administration (USFDA) for the treatment of hemophilia A, a type of inherited bleeding disorder.
The French drugmaker is set to launch the therapy in the United States in April, entering a market where factor replacement therapies have been the standard treatment for decades.
Altuviiio: A Potential Best-in-Class Therapy
Factor replacement therapies have been used to replace the missing blood clotting factor and allow blood to clot properly by injecting treatment products into a patient’s vein.
With Sanofi’s new drug, Altuviiio, the company is expected to enter the market with one of the best-in-class therapies, according to Damien Conover, a Morningstar analyst. Barclays analyst Emily Field also predicts global peak sales of €2.3 billion.
Pricing and Competition
Currently, the average annual cost of clotting factor therapies is around $300,000. Sanofi is expected to price Altuviiio slightly higher than traditional factor therapies, with the drug priced at parity to the annual cost of treating a prophylaxis patient on Eloctate.
The French drugmaker gained access to Eloctate and Altuviiio through the $11.6 billion acquisition of U.S. hemophilia specialist Bioverativ in 2018.
Altuviiio’s approval also offers patients an alternative to Roche’s Hemlibra, which is the current market leader for this indication.
However, it is anticipated that Altuviiio will only take share from other factor therapies and not from Hemlibra in the first few years following its launch, according to Field.
Conclusion
Hemophilia A is a genetic disorder that causes a missing or defective factor VIII clotting protein.
Sanofi’s Altuviiio is now a viable treatment option for those with this condition and is expected to make a significant impact on the market.
With its potential as a best-in-class therapy, Sanofi is poised to make a strong entrance into the competitive world of hemophilia A treatment.
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