With a final vote of 18-1, the bone, reproductive and urologic drugs advisory committee (BRUDAC) wrapped up a hearing on Wednesday with a recommendation that the US Food and Drug Administration (FDA) approve Amgen and UCB’s Evenity (romosozumab) osteoporosis treatment.
The BRUDAC hearing on Wednesday marked Amgen and UCB’s second review for Evenity. The new recommendation comes after FDA issued
a Complete Response Letter in July 2017 for the Biologics License Application (BLA) for the Evenity injection, with a proposed use indication of treatment for postmenopausal women with osteoporosis. Evenity is now up for approval with a narrower indication.
The committee voted in favor of the indication proposed in Amgen’s and UCB’s July 2018 BLA resubmission. The indication was further limited for the “treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as history in osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.” The change was made because of concerns about a lack of data to analyze potential cardiovascular risks.
There was consensus among advisory committee members to conduct a post-approval study in order to obtain real-world data (RWD) in a clinical setting on cardiovascular risk. Yet some BRUDAC members also argued that it would be “impossible” to conduct the recommended post-approval study and obtain such RWD, citing challenges with enrollment in clinical settings.
BRUDAC’s decision was largely based on its review of the safety and efficacy data generated via pivotal Phase III studies, including the FRAME trial and the ARCH trial. The committee ultimately recommended approval because Amgen had already agreed to add a boxed warning to Evenity.
“Despite available therapies, these women who are at high risk for fracture could benefit from an additional treatment option that has the potential to both build new bone and slow existing bone loss,” said
David Reese, executive vice president of research and development at Amgen. “We are committed to working with the FDA to help make EVENITY available to appropriate patients."
The BRUDAC member that voted against recommending FDA approval with Amgen’s newly proposed indication cited the lack of data on cardiovascular risks and called for another pre-approval study.
“I voted no almost for the same reasons people voted yes,” said BRUDAC patient representative Natalie Compagni-Portis. “I think there is a great need and there is real potential with this drug. I think we might find out with doing research that we could very widely and safely prescribe” Evenity but “it behooves us to clarify the safety issues prior” to FDA’s approval, she said.