US regulators have issued a green light for Roche’s haemophilia A therapy Hemlibra and also expanded the scope of Gazyva to include untreated advanced follicular lymphoma.
Hemlibra (emicizumab-kxwh) has been cleared for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.
According to Roche, nearly one in three people with severe haemophilia A can develop inhibitors to factor VIII replacement therapies, which puts them at greater risk for life-threatening bleeds or repeated bleeds that can cause long-term joint damage.
Hemlibra “has been shown to reduce the frequency of bleeds compared to the currently available medicines and only needs to be injected once a week. This could make a meaningful difference for these children,” noted Guy Young, director of Hemostasis and Thrombosis Program, Children’s Hospital Los Angeles, and Professor of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, California.
Underpinning the approval was data from the Phase III HAVEN 1 study, which showed that people 12 years of age or older with haemophilia A with inhibitors who received Hemlibra prophylaxis had a statistically significant reduction in treated bleeds of 87 percent compared to those who received no prophylaxis.
Also, in a first-of-its-kind intra-patient analysis, Hemlibra prophylaxis resulted in a statistically significant reduction in treated bleeds of 79 percent versus previous treatment with bypassing agent (BPA) prophylaxis collected in a non-interventional study (NIS) prior to enrolment, Roche noted.
Elsewhere, the FDA also expanded the use of Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma.
The approval is based on results from the phase III GALLIUM study, which showed that the Gazyva-based regimen significantly cut the risk of disease worsening or death compared to a Rituxan (rituximab)-based regimen by 28 percent.
The drug is currently approved in more than 80 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia (CLL), in combination with bendamustine for people with certain types of previously treated follicular lymphoma, in combination with chemotherapy for previously untreated, follicular lymphoma.
Meanwhile, Roche also announced plans to aquire an agreement with Viewics, Inc, a privately held software company focused on laboratory business analytics.
Under the deal, Roche is acquiring all shares of the firm for an undisclosed amount, with the aim of expanding its position in the Integrated Core Lab with business analytics capabilities, enabling laboratories to make faster data-driven informed decisions on their operations and processes.