Roche Unveils New Hemlibra Data Reinforcing Safety Profile In Hemophilia A

According to Roche Holding AG's RHHBY Genentech division, new data from a phase 3b study reinforces the safety profile of blockbuster hemophilia A treatment Hemlibra.
The new safety data from the Phase 3b STASEY study revealed that Hemlibra was effective with no new safety signals identified in adults and adolescents with hemophilia A with factor VIII inhibitors.
The final analysis included data from 193 hemophilia A patients who received Hemlibra prophylaxis once weekly for up to two years.
The analysis did not show any new cases of thrombotic microangiopathy or severe thrombotic events related to Hemlibra.
In addition, the STASEY study reinforced that Hemlibra is associated with a low incidence of anti-drug antibody (ADA) development.
Ten (5.2%) participants tested positive for ADAs, five (2.6%) of whom were classified as having ADAs that were neutralizing in vitro.
In all 10 participants, ADA development did not affect the efficacy or safety of Hemlibra.
Hemlibra demonstrated effective bleed control, with 82.6% of participants experiencing no bleeding episodes that required treatment.
Annualized bleeding rates were consistent with previously reported observations from the pivotal HAVEN studies.
Price Action: RHHBY shares closed at $48.63 on Friday.