AstraZeneca’s Farxiga Fails to Yield Statistical Significance for Covid-19 Treatment

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  • The Phase 3 trial of Farxiga (dapagliflozin) as a treatment for Covid-19 did not show any statistical significance.
  • The trials have resulted in collection of important data on the likely benefits and concerns of using SGLT2 inhibitors to treat Covid-19 patients admitted to hospital.

Things are not at all smooth for the pharma major AstraZeneca Plc (LON: AZN). After getting mired in various controversies related to its Covid-19 vaccine (ChAdOx1 S), it has received another setback. The Phase-III trial of Farxiga (dapagliflozin) as a treatment for Covid-19 did not show any statistical significance for the patients susceptible to developing major problems.

The company has reported that its oral diabetes drug Farxiga, a first-in-class once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor, was unable to result into any statistical significance in gathering the key endpoint of inhibition. Also, in measuring organ dysfunction and all-cause death and the initial major endpoint of recovery gauging a change in clinical status from early recovery to death, at 30 days in trial.

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Phase-III trial

In DARE-19 Phase III trial for assessing the safety and effectiveness of SGLT2 inhibitor in patients who were under treatment for COVID-19, who had different risk factors for developing major complications, including heart failure or chronic kidney disease, Stages 3-4.1, ASCVD (atherosclerotic cardiovascular disease), hypertension, T2D (type-2 diabetes, atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD) Stages 3-4.1,2 Cardiac, renal and metabolic comorbidities,  was conducted at the Saint Luke's Mid America Heart Institute, but despite high-level results of the primary analysis, statistical significance could not be achieved.

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However, Mikhail N. Kosiborod, cardiologist at Saint Luke's Mid America Heart Institute, who is also principal investigator of the trial, said that though the trial of using SGLT2 inhibitors failed to accomplish statistical significance, it has yielded important data on the potential benefits and concerns of its uses to treat COVID-19 impacted patients in hospital.

He added that the trial findings are noteworthy and would be beneficial for future clinical science.

It was reported that the safety and acceptability profile for Farxiga at 30 days in the trial was in consonance with the well-recognised profile of the medicine and that dapagliflozin's already proven safety profile remained stable in DARE-19. At the ACC Scientific Session – (American College of Cardiology Scientific Sessions) in May this year, the full outcome of the DARE-19 trial results will be presented.

For almost 10 years, Farxiga is being used and considered as an effective monotherapy and part of combination therapy as an addition to diet and exercise for adult patients with Type-2 diabetes glycaemic control.

The result of the trial though has not much impacted the pharma major’s stocks on LSE. AZN shares continue to trade marginally in red at GBX 7,277.00, down by 0.14 per cent at 9:40 AM GMT +1 on 12 April.