Domingo, 23 Julio, 2017

FDA Rejects Amgen-UCB Osteoporosis Candidate Evenity

US regulators turn away Amgen/UCB's bone drug Evenity FDA rejects Amgen's osteoporosis hope romosozumab
Danilo Martir | 17 Julio, 2017, 21:18

The FDA has turned down Amgen's marketing application for osteoporosis candidate romosozumab, asking for new data that could delay any approval significantly.

With the availability of data from the Phase 3 active-comparator ARCH study, the agency has asked that the efficacy and safety data from the study be integrated into the application. Radius said on April 28 that the FDA approved Tymlos for postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Federer up to ATP No. 3 after Wimbledon; Muguruza WTA No. 5
Turns out six months away from the tour were all that was needed to enliven the game of tennis' most spectacular showpiece. Hopefully I can just be humble, keep working and don't expect to perform incredible every match because it is not the case.

As expected, the U.S. regulator wants to see data from the recently-completed ARCH trial of the anti-sclerostin antibody added into the marketing application, along with the results of the BRIDGE study in men with osteoporosis, which means the application will have to be re-filed.

This request will be addressed in the form of a resubmission, which Amgen said is an extension of the current review. "We look forward to working through the review process with the Agency", stated Sean E. Harper, M.D., the executive VP of research and development at Amgen.

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The resubmission will also include the efficacy and safety data from the BRIDGE study, a Phase III trial assessing Evenity (romosozumab) in men with osteoporosis, which has also been requested by the FDA. He also pointed out that Amgen plans to invest more time towards understanding the risk and benefit profile of EVENITY. UCB Vice President Dr. Pascale Richetta stated that a woman with a fragility fracture has five times more likely to suffer another one within 12 months. "This is a stark reminder that there is an urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in the future".

"With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures", Richetta added.

Chemours Co (CC) Analysts See $0.71 EPS
In other news, insider Paul Kirsch sold 19,036 shares of the business's stock in a transaction that occurred on Monday, June 5th. Cypress Capital Management LLC WY raised its position in shares of Chemours Company (The) by 1.9% in the first quarter.

Amgen stock closed the latest trading session on Friday at $117.13.

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