Viernes, 24 Noviembre, 2017

FDA Rejects Amgen-UCB Osteoporosis Candidate Evenity

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.

Las ciudades mas inseguras
Este porcentaje de población presenta un cambio significativo respecto a marzo de 2017 y a junio de 2016. La ENSU, con periodicidad trimestral, ha realizado a la fecha dieciséis levantamientos.

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.

La tercera temporada llegará a Netflix el 1 de septiembre — Narcos
La nueva entrega se centra en los acontecimientos ocurridos después de la muerte de Pablo Escobar, por lo que la DEA enfoca su atención en el Cártel de Cali.

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

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