LONDON, May 22 (APM) - Amgen and UCB said their experimental osteoporosis drug romosozumab met the primary and key secondary goals of a late-stage study, but higher rates of serious heart problems were reported that had not been seen in earlier studies.
The drug, which is awaiting U.S. approval, will be sold under the brand name Evenity if approved.
The two pharmas said in a joint Sunday statement that the EVENITY (romosozumab) ARCH study met both primary endpoints and the key secondary endpoint.
Evenity significantly reduced the incidence of new vertebral fractures through 24 months and non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture compared with Merck & Co's Fosomax (alendronate).
However, serious heart-related side-effects were reported in 2.5% of patients who received the Amgen drug versus 1.9% in the Fosomax group.
Head of research and development at Amgen Dr Sean Harper said: "The efficacy results from this study comparing Evenity to an active control are robust.
"At the same time, the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit:risk profile for Evenity. Together with UCB, we will engage with global regulators and medical experts in the field to conduct a thorough evaluation of these data."
In this study, women received a subcutaneous injection of Evenity monthly for 12 months followed by oral alendronate weekly for at least 12 months.
At 24 months, women in the Evenity treatment group experienced a statistically significant 50% reduction in the relative risk of a new vertebral fracture compared to those receiving alendronate alone.
Women in the Evenity treatment group also experienced a statistically significant 27% reduction in the relative risk of clinical fracture (non-vertebral fracture and clinical vertebral fracture) at the primary analysis.
Additionally, non-vertebral fractures were statistically significantly reduced by 19% in the Evenity treatment group, including a nominally significant reduction in hip fractures, the companies said.
UCB's chief medical officer Dr Iris Loew-Friedrich said: "We are impressed with the statistically significant superior fracture risk reduction of Evenity over alendronate, a current standard of care in osteoporosis.
"When we think that patients who have had a fracture are highly likely to suffer another one, the importance of post-fracture care cannot be emphasised enough. We are working on understanding the observed cardiovascular safety signal and will continue to discuss these results with global regulators and experts in the field."
Filings are under review in the U.S., Canada and Japan.
Amgen said it has agreed with the U.S. Food and Drug Administration that the ARCH data should be considered in the regulatory review prior to the initial marketing authorisation, and as a result the company does not expect approval in the U.S. in 2017.
Preparations for a European filing will continue as planned. Further analysis of the Phase III ARCH study data is ongoing and will be submitted to a future medical conference and for publication, the companies said.
The companies have said previously that in the U.S., one in two women over the age of 50 will experience an osteoporotic fracture and that only 20% of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post-fracture. (APMMA 49736)
Romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption, the companies have said.
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