UCB: osteoporosis drug fails to win US approval.
(CercleFinance.com) - Belgian drugmaker UCB and US partner Amgen said on Sunday that US regulators rejected Evenity, their investigational monoclonal antibody, for the treatment of postmenopausal women with osteoporosis.
The two companies announced that the US Food and Drug Administration (FDA) has issued a so-called "complete response letter" for the application on the drug.
"This was anticipated as the original filing to the FDA only included results from the Frame phase III trial which despite having reached its primary endpoint (...) failed to show a statistical significance in the reduction of non-vertebral fractures and raised safety concerns," Bryan Garnier commented today.
However, UCB shares were not really reacting to the news this morning on Euronext Brussels, adding 0.4% to 60.7 euros.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The two companies announced that the US Food and Drug Administration (FDA) has issued a so-called "complete response letter" for the application on the drug.
"This was anticipated as the original filing to the FDA only included results from the Frame phase III trial which despite having reached its primary endpoint (...) failed to show a statistical significance in the reduction of non-vertebral fractures and raised safety concerns," Bryan Garnier commented today.
However, UCB shares were not really reacting to the news this morning on Euronext Brussels, adding 0.4% to 60.7 euros.
Copyright (c) 2017 CercleFinance.com. All rights reserved.