New data from a phase 3b study reinforces the safety profile of blockbuster haemophilia A treatment Hemlibra, according to Roche’s Genentech division.
The drug is continually proving to be a star performer for Roche globally, having brought in CHF 1.38bn ($1.47bn) in 2019, its second full year on the market. The monoclonal antibody was approved in the EU for routine prophylaxis of bleeding episodes in people with haemophilia A, also known as patients with inhibitors, in March 2018, although it was first approved by the US Food and Drug Administration (FDA) in 2017. Inhibitors are antibodies that bind to factor VIII drugs and stop them from working properly.
This was swiftly followed by a wider approval by the FDA in October 2018 for patients without inhibitors. That broader indication allowed Roche to challenge a range of factor VII drugs in the marketplace, including both short-acting and newer long-acting versions such as Shire’s Adynovate, Biogen’s Eloctate, Bayer’s Kovaltry and CSL Behring’s Afstyla. It has the advantage of being dosed every one, two or four weeks depending on need compared to the multiple dosing required for these other drugs.
It’s this broader market and flexible dosing that has allowed Hemlibra to grow into a blockbuster treatment, and helped to transform the treatment of haemophilia A since its launch. The new safety data from the phase 3b STASEY study, revealed today, will continue to build on the drug’s stronghold in the market.
In the STASEY study, Hemlibra was effective with no new safety signals identified in adults and adolescents with haemophilia A with factor VIII inhibitors, which was consistent with previous safety observations.
Further new interim data suggests that people on Hemlibra may also be able to undergo certain minor surgeries without additional preventative (prophylactic) coagulation factor. The majority of minor surgeries were performed without the use of prophylactic coagulation factor (64.5%) and 85% did not result in treated post-operative bleeds.
“This important safety data continues to add to the extensive clinical evidence reinforcing Hemlibra’s potential to redefine the standard of care for people with haemophilia A,” said Levi Garraway, chief medical officer and head of global product development of Roche.
“The STASEY study reflects our continued focus on providing valuable insights that meet the needs of the haemophilia community and enhance our understanding of Hemlibra in clinical practice,” he added.