Halozyme Therapeutics, Inc. announced that the EU Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approve Roche's subcutaneous (SC) formulation of MabThera(R) (rituximab) using Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL). Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation comes as a ready-to-use, fixed dose, 1,400 mg solution, which shortens pharmacy preparation time and reduces the overall impact on hospital resources.

The CHMP opinion is based primarily on data from Roche's Phase 3 SABRINA study. Roche expects a final decision from the European Commission in the coming months.