Pfizer has been granted approval from the FDA for its haemophilia drug, Hympavzi.
The therapeutic is suitable for use in patients over 12 years of age, and is recommended for patients with both haemophilia A and B.
According to Pfizer, Hympavzi is the first and only anti-tissue factor pathway inhibitor that has been approved in the US for this indication.
It is also the first medicine for haemophilia that has been approved for auto-injection.
Hympavzi offers a patient-centric dosing regime, as it can be given subcutaneously once a week.
The injectable's approval stems from the results of the Phase III BASIS trial, which reduced the annualised bleeding rate of patients by 35% and 92% within the 12 month treatment period.
As well as the FDA approval of Hympavzi, Pfizer's marstacimab has also received a positive opinion from the CHMP division of the EMA, potentially signalling its approval for the routine prophylaxis of bleeding episodes in patients aged 12 and over with severe haemophilia A and B.
Beqvez, Pfizer's haemophilia B gene therapy, has now also been cleared for use in the US, EU and Canada.
“The approval of HYMPAVZI is a meaningful advancement for people living with hemophilia A or B without inhibitors for bleed prevention, with a generally manageable safety profile and a straightforward once-weekly subcutaneous administration,” said Suchitra S. Acharya, M.D., Director, Hemostasis and Thrombosis Center Northwell Health, Program Head, Bleeding Disorders and Thrombosis Program, Cohen Children’s Medical Center. “HYMPAVZI aims to reduce the current treatment burden by meeting an important need for these patients, including many who have required frequent, time-consuming intravenous treatment infusion regimens.”
Pfizer's Chief US Commercial Offcier and Executive Vice President, Aamir Malik, commented: “HYMPAVZI is Pfizer’s second hemophilia treatment to receive FDA approval this year and is the latest meaningful scientific advancement in our more than 40-year commitment to improve care for people living with hemophilia,”
“We look forward to launching this latest medical breakthrough and to now offer three distinct classes of hemophilia medicines – an anti-TFPI, gene therapy, and recombinant factor treatments – that can meet the unique treatment needs of a wide range of patients.”