Heart Drug Updates: Fast Track for Farxiga after MI, Brilinta Plus Aspirin After Stroke or TIA, NDA for Vericiguat

On Thursday, FDA took a step toward another indication for Farixga, which earlier this year became the first type 2 diabetes drug also approved for heart failure. Under a Special Protocol Assessment, FDA granted a Fast Track Designation based on a collaborative design that will integrate routine care with registries to spare patients the need for added travel. Called DAPA-MI trial, the trial for the SGLT2 inhibitor will start in the fourth quarter of 2020. Farixga (dapagliflozin, AstraZeneca), was also able to halt the DAPA-CKD trial in March after an independent panel found “overwhelming efficacy” in chronic kidney disease.

Full results for Brilinta with aspirin were published in the New England Journal of Medicine Thursday, a week after FDA accepted Astra Zeneca’s supplemental New Drug Application (sNDA) and granted priority review for the blood thinner to treat prevent a second stroke in patients after an initial ischemic stroke to transient ischemic attack, or TIA. Action is expected in the fourth quarter of 2020. About 1 in 4 patients who have a stroke event go on to have another, often within 30 days. The combination of Brilinta (ticagrelor) with aspirin, which had not been well studied, was shown to reduce the risk of a second stroke by 17% compared with aspirin alone.

Merck this week received priority review for vericiguat, an investigational oral soluble guanylate cyclase (sCG) stimulator to cut the risk of cardiovascular death and heart failure hospitalization after an event in certain patients with chronic failure, the company announced.
In announcing the NDA, the company said action under the Prescription Drug User Fee Act is required by January 20, 2021. This filing follows presentation of phase results from the VICTORIA trial in late March at the American College of Cardiology, which showed that for the sickest patients with heart failure and reduced ejection fraction who show signs of decline with standard treatments, vericiguat can stem this progression. Compared with placebo, patients taking vericiguat had fewer events, less hospitalization, and less risk of death. Merck is developing the drug with Bayer AG.