AstraZeneca secures accelerated FDA review for Farxiga for for CV death following heart attacks
pharmafile | July 17, 2020 | News story | Medical Communications, Research and Development, Sales and Marketing | AstraZeneca, FDA, farxiga, fast track
AstraZeneca has made it known that Farxiga (dapagliflozin) has secured Fast Track Designation from the FDA for the reduction of hospitalisation risk for heart failure (hHF) or cardiovascular (CV) death in adult patients following an acute myocardial infarction (MI) or heart attack.
This designation is generally only awarded in indications that are plagued by unmet need. A common cause of heart failure, acute MI affects around seven million patients around the world each year, and the condition has not seen any new treatments in over a decade.
The therapy is due to be tested in a Phase 3 trial incorporating 6,400 patients from approximately 50 sites in Sweden and 50 sites in the UK. The study also received a Special Protocol Assessment (SPA) agreement from the FDA to designate its design is fit for an eventual marketing application if Farxiga proves successful.
AZ confirmed that the trial would be open to patients participating via data registries, removing the need for them to travel to clinical trial sites – a key concern during the COVID-19 pandemic. It is expected to begin recruitment in the fourth quarter of this year.
“The Phase 3 DAPA-MI trial is the first indication-seeking registry-based randomised controlled trial which will provide quicker access to data and reduce recruitment time and cost, while minimising patient and investigator burden,” commented Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AZ. “Today’s FDA decision acknowledged the importance of this trial, which will provide valuable insights into Farxiga’s potential in patients who had a heart attack and went on to develop heart failure and also into how we can improve clinical trial design in the future.”
Matt Fellows
Related Content
EndoCyclic New Drug application approved by US FDA for endometriosis treatment
EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved …
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
