EC approves treatment for severe osteoporosis postmenopausal women

Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.

The European Commission (EC) has granted marketing authorisation for Evenity® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

…[Evenity is] a new medicine that can help drive positive changes in secondary fracture prevention”

The drug is a novel bone-building monoclonal antibody (mAb) with a dual effect that increases bone formation and to a lesser extent reduces bone resorption.

Evenity is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation.

Amgen and UCB, which produce the drug, conducted a development programme that includes 19 clinical studies with approximately 14,000 patients enrolled.

“Evenity is a significant step forward in the management of osteoporosis for physicians who need to treat patients with a medicine that can rapidly increase bone mineral density within 12 months,” said Dr David Reese, Executive Vice President of R&D at Amgen. “We are pleased by the EC’s approval to make this therapy available to the millions of women at high risk of fracture in the EU.”

“With today’s approval of Evenity we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention,” said Dr Pascale Richetta, Head of Bone and Executive Vice President, UCB.

The first launches of the drug are expected in the first half of 2020.