Halozyme Announces Positive Opinion from CHMP on Roche's Herceptin SC for European Approval
Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that Roche received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the subcutaneous formulation of Herceptin^® (trastuzumab) using Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of patients with HER2-positive breast cancer in Europe.
Roche's pivotal Phase 3 HannaH study, conducted in 102 sites outside the US, demonstrated that Herceptin SC may help decrease the time patients spend receiving treatment at a hospital or physician's practice, by reducing the administration time. A typical IV infusion of Herceptin can take 30 to 90 minutes, per dose, whereas the same dose delivered subcutaneously can be administered in two to five minutes by an injection under the skin.^1
"Pending European approval, this subcutaneous formulation of Herceptin will provide a new route of administration that could potentially save time for both physicians and HER2-positive breast cancer patients in Europe," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme Therapeutics. "We are pleased that our technology has helped enable this new option for patients."
Study results showed that the safety and efficacy of the subcutaneous formulation of Herceptin is comparable to treatment with Herceptin administered intravenously.^1 Overall, the safety profile in both arms of the HannaH study was consistent with that expected from standard treatment with Herceptin and chemotherapy in this setting. No new safety signals were identified.
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