Phase III STRENGTH trial for Epanova in mixed dyslipidaemia will close
Posted: 14 January 2020 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
On recommendations by an independent committee, AstraZeneca will close its STRENGTH trial for Epanova, which has shown low likelihood of being beneficial to patients with mixed dyslipidaemia.
AstraZeneca has announced its decision to close the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids) on the recommendation of an independent Data Monitoring Committee. The committee concluded Epanova was unlikely to demonstrate a benefit to patients with mixed dyslipidaemia (MDL) who are at increased risk of cardiovascular disease (CVD).
We are… grateful for the opportunity to conduct the STRENGTH trial as an exemplary collaboration between academic physicians and industry”
STRENGTH is a large-scale, global CVD outcomes trial designed to compare Epanova 4mg daily to a (corn oil) placebo. It was primarily set up to evaluate the safety and efficacy of the treatment on reducing the risk of major adverse cardiovascular events (MACE) in patients with mixed dyslipidaemia who are at high risk for CVD despite optimal statin therapy. A total of 13,086 patients were enrolled at 675 sites in 22 countries.
Dr Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, explained: “It was important to assess the potential benefit of Epanova in mixed dyslipidaemia. We are disappointed by these results, but we remain committed to addressing the needs of patients in the cardiovascular space where we have an extensive pipeline.”
Dr Steven Nissen, Study Chair for the STRENGTH trial and Chief Academic Officer for the Heart and Vascular Institute, Cleveland Clinic, US, said: “The academic leadership of the STRENGTH trial is obviously disappointed in this result, but we are very proud to have had the opportunity to answer this important scientific question. We are also grateful for the opportunity to conduct the STRENGTH trial as an exemplary collaboration between academic physicians and industry.”
This trial will now be closed and full data will be presented at a medical meeting.
Clinical Development, Clinical Trials, Drug Safety, QA/QC, Research & Development (R&D)
AstraZeneca, BioPharmaceuticals R&D, Heart and Vascular Institute