Drug Approvals

European regulators won't back Amgen/UCB drug

Jun 28, 2019

Amgen and Belgian partners at UCB announced that the EMA has adopted a negative opinion on Evenity, for the treatment of osteoporosis in men and in postmenopausal women at increased risk of fracture.

The opinion of the Committee for Medicinal Products for Human Use (CHMP) is based on results from a large development program including three pivotal Phase 3 studies comprised of nearly 12,000 patients. The osteoporosis drug was approved by the U.S. FDA in April 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, but will come with the agency’s strictest warning — a boxed label restricting women who have had a heart attack or stroke in the previous year from using the medication.

The drug is also approved in Japan, South Korea and Canada.

The companies intend to submit a written notice for a re-examination by the CHMP.

Read the press release.

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