AZ acalabrutinib submission accepted by US FDA
This announcement contains inside information 02 August 2017 07:00 BST US FDA ACCEPTS REGULATORY SUBMISSION FORACALABRUTINIB AND GRANTS PRIORITY REVIEW AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor. The NDA is based on results from the Phase II ACE-LY-004 clinical trial, which evaluated the safety and