Health Canada approvals for Amgen and AstraZeneca

There were two important drug approvals for medicines regulator Health Canada today, the first being US biotech major Amgen’s (Nasdaq: AMGN) new humanized anti-sclerostin monoclonal antibody for osteoporosis.

Amgen Canada announced that Evenity (romosozumab-aqqg) is now available in Canada for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture.

In the USA, Evenity launched in April this year at a US list price of $1,825 per dose, or $21,900 for a full course of treatment (12 monthly doses).

"We are pleased with Health Canada's decision to approve Evenity and allow patients access to a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures," says Ponda Motsepe-Ditshego, executive medical director at Amgen Canada, adding: "Two million Canadians are affected by osteoporosis, and this approval provides a new option for physicians when treating patients who may be at risk."

The Canadian approval of EVENITY was based on the results of two Phase III studies that demonstrated a reduction of new vertebral (spine) fractures and increased bone mineral density (BMD).

Agency also backs Calquence for MCL