AstraZeneca ends Phase IV Andexxa trial after positive results
The company will now seek full-label approval for the bleeding reversal agent in the US and EU.
AstraZeneca has announced it would stop Andexxa’s Phase IV trial after the study achieved its aims earlier than expected.
The ANNEXA-I study (NCT03661528) was designed to assess the use of Andexxa (adexanet alfa) in patients on an oral Factor Xa (FXa) inhibitor treatment including Eliquis (apixaban), which is marketed in the US by Pfizer and Bristol Myers Squibb, and Janssen’s Xarelto (rivaroxaban), who were experiencing an intracranial haemorrhage.
Andexxa is a modified form of the FXa molecule, an enzyme responsible for blood clotting. The drug works by acting as a decoy for FXa inhibitors, anticoagulants, that would usually bind to the FXa molecule to produce the anticoagulant effect. The treatment had been granted accelerated approval in the US. Under the name Ondexxya, it is also approved in Japan, and conditionally approved in the EU, UK and Switzerland, to treat patients on FXa inhibitors.
The study was stopped after a recommendation from the independent Data and Safety Monitoring Board (DSMB) following a planned interim assessment of efficacy. These early results will be a boon for AstraZeneca, which is currently seeking to broaden its cardiovascular, renal and metabolism offerings, believing it to be a key growth driver for the company.
Millions of people depend on FXa inhibitors to manage potential blood clots; however, they carry a risk of acute major bleeds, necessitating fast acting reversal agents to maintain patient health.
AstraZeneca will now proceed with regulatory filings in the US and EU to convert to full label approval, with full results from the trial to be presented at a forthcoming medical meeting.
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