Sanofi prepping for April rollout of hemophilia A therapy Altuviiio

Sanofi says it is working with its third-party manufacturing partner to make its recently approved factor VIII therapy Altuviiio available from April.

Last week, the US Food and Drug Administration (FDA) approved Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], Sanofi’s factor VIII replacement therapy.

The therapy has been described as a first-in-class treatment for the treatment of patients with hemophilia A, delivering a normal to near-normal factor activity levels (over 40%) for most of the week through a single dose.

Image: DepositPhotos/vitanovski

“The high sustained factor activity levels that can be achieved with Altuviiio have the potential to change the hemophilia landscape,” said Sanofi CEO Paul Hudson. “For the first time, with a once-weekly dose, powerful bleed protection is a reality for patients.”

According to the FDA label information, the therapy is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line. It also names Bioverativ Therapeutics as the manufacturer.

Sanofi acquired Bioverativ in 2018 for $11.6 billion, adding Altuviiio, then known as efanesoctocog alfa, along with several other hemophilia assets. Bioverativ itself span out from Biogen in 2017 and, at the time, continued to leverage Biogen’s manufacturing network to support the drug substance and drug product of its clinical pipeline.

While Sanofi did not divulge where Altuviiio is being produced – nor whether Biogen’s network is still involved – a spokesperson did say the product is made at a contract development and manufacturing organization (CDMO).

“We anticipate a significant demand and are planning to have the adequate quantities available to serve all patients’ needs,” BioProcess Insider was told. As such, the firm is prepping to scale up production to support the proposed rollout.

“Our unwavering commitment to the community means ensuring a sufficient quantity is produced before product availability. We anticipate product availability in April 2023, and are working closely with our manufacturing partner to ensure ongoing coverage of production needs.”