BMS on tenterhooks over belatacept future
pharmafile | May 4, 2010 | News story | Research and Development |Â Â BMS, belataceptÂ
Bristol-Myers Squibb has been kept on tenterhooks by US regulator the FDA over the future of its investigational kidney transplant drug belatacept.
In March an FDA Advisory Committee panel voted decisively to recommend the selective co-stimulation blocker to prevent organ rejection in adult patients receiving kidney transplants.
A final decision was expected this month – but in a complete response letter this week, the authorities have now asked for 36-month data from its phase III studies so it can further evaluate the drug’s long-term effects.
BMS points out that no new clinical studies have been requested and pledges to “work with the FDA to provide the data as soon as they are available”.
The company had included 24-month data in its licence application last September – but the FDA now wants more information on the drug’s manufacture and the risk evaluation and mitigation strategy that BMS has developed.
“Bristol-Myers Squibb is committed to belatacept as a potential new therapeutic option for kidney transplant patients,” insisted Brian Daniels, the company’s senior vice president, global development and medical affairs.
“We will continue to work closely with the FDA to address their questions,” he added.
Belatacept is a fusion protein designed to be a selective T cell co-stimulation blocker that binds to a specific site on antigen presenting cells of the immune system.
These are thought to block the second signal necessary to activate T cells – the cells which influence whether an organ is rejected.
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