Us Fda Approves Sanofi’s Bleeding Disorder Therapy

Us Fda Approves Sanofi’s Bleeding Disorder Therapy

The French pharmaceutical company Sanofi SA (SASY.PA) announced on Thursday that the U.S. The Food and Drug Administration had authorized its medication to treat a specific form of genetic bleeding illness known as hemophilia A and anticipated its April debut in the country.

In a market dominated by competitors like Takeda Pharmaceutical (4502.T), Bayer AG (BAYGn.DE), and Novo Nordisk (NOVOb.CO), which sell factor replacement therapies that have been the standard of care for decades, Sanofi’s replacement medication, Altuviiio, is making its debut.

Before the approval, Damien Conover of Morningstar predicted that Sanofi’s medication would rank among the best in its class.

Global peak sales are expected to reach 2.3 billion euros, according to Barclays analyst Emily Field.

The average yearly cost of currently available clotting factor therapy is around $300,000. At least two analysts predicted Sanofi’s medicine would cost slightly more than the established factor therapies before the approval.

Sanofi, which co-developed the medication with Swedish pharmaceutical company Sobi (SOBIV.ST), said it will cost the same per year to treat an Eloctate prophylaxis patient as it does for Altuviiio.

Elocate and Altuviiio were acquired by the French pharmaceutical company through the separation of American hemophilia specialist Bioverativ from Biogen Inc. in 2018 and subsequent $11.6 billion takeover.

Also, patients now have an option to Roche’s (ROG.S) market-leading medication Hemlibra, according to the FDA’s clearance.

According to Field, “I think the majority of doctors are thinking that Altuviiio will only gain share from the other factor therapies and not from Hemlibra for the first couple of years of the launch.”

Factor VIII, a clotting protein, is either absent or faulty in haemophilia A, a hereditary condition.

On February 23, 2023, the FDA approved Altuvioo, a factor VIII replacement medicine from Sanofi (Antihemophilic Factor [Recombinant] Fc-VWF-XTEN Fusion Protein-ehtl). For both adults and children with hemophilia A, the medication is suggested for routine prophylaxis, on-demand treatment to stop bleeding episodes, and perioperative care.

The key XTEND-1 Phase III research, which demonstrated that once-weekly prophylaxis met the primary aim of providing considerable bleed protection for individuals with severe hemophilia A, provided evidence on which the FDA based its approval in part. The mean annualized bleeding rate (ABR) and median ABR for the treatment were 0.70 and 0.0, respectively. Also, based on an intra-patient comparison, it fulfilled the primary secondary endpoint with a significant 77% reduction in ABR compared to previous factor prophylaxis.

According to Paul Hudson, CEO of Sanofi, in a news release from the firm, “Today’s approval of [Antihemophilic Factor (Recombinant) Fc-VWF-XTEN Fusion Protein-ehtl] allows patients and physicians to rethink living with hemophilia.” “[Antihemophilic Factor (Recombinant) Fc-VWF-XTEN Fusion Protein-ehtl] has the potential to alter the hemophilia landscape due to its high sustained factor activity levels. For the first time, patients can have effective bleed prevention with a once-weekly dose.

The FDA granted priority review, breakthrough treatment, fast track, and orphan medication designations before approving Antihemophilic Factor (Recombinant) Fc-VWF-XTEN Fusion Protein-eht. In the second half of 2023, a regulatory submission to the European Union is anticipated.

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