Baxter spin out Baxalta has unveiled data showing that its long-acting haemophilia drug Adynovate is better than predecessor Advate at clotting blood and preventing serious bleeds.
Data from the Phase II/III pivotal study and Phase I trial published in Blood, the journal of the American Society of Haematology, showed that of Adynovate (also BAX 855) generated a mean half-life extension of 1.4- to 1.5-fold compared with Advate, the world’s most prescribed factor VIII treatment.
Patients in the twice-weekly prophylaxis arm of the trial experienced a 95% reduction in median annualised bleed rate versus those in the on-demand arm (1.9 versus 41.5, respectively), while the drug was also effective in treating all bleeding episodes, 95.9% of which were controlled with one or two infusions.
On the safety side, no patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity reactions, were reported.
The results form the basis of a marketing application in the US.
“Adynovate has the potential to offer an important new option for patients, providing the combination of bleed prevention with a simple, twice-weekly dosing schedule,” said Leonard Valentino, global head, Haematology Medical Affairs at Baxalta. “The results of this pivotal trial demonstrate the ability of Adynovate to help further personalise treatment regimens to minimise the impact that haemophilia has on patients’ lives,” he noted.
If successful, the drug could find itself up against several long-acting haemophilia drugs on the market, such as Biogen’s already approved Eloctate, Bayer’s late-stage experimental factor VIII replacement therapy BAY 94-9027, and others.