Benzinga | Jul 19, 2021 08:18AM EDT

Roche Unveils New Hemlibra Data Reinforcing Safety Profile In Hemophilia A

* According to Roche Holding AG's (OTC: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.