2 days ago
FDA Approves Triple Rx for Hypertension
The FDA has approved Widaplik, a triple-drug combination, for the treatment of hypertension in adults.
Widaplik combines three drugs — telmisartan, amlodipine, and indapamide — into a single pill that will be available in three doses: 10/1.25/0.625 mg; 20/2.5/1.25 mg, and 40/5/2.5 mg. Intended as initial therapy for patients likely to need multiple medications to control hypertension, the product is expected to be on the market by the end of 2025.
The FDA approval for the combination pill was based in part on data from two pivotal phase 3 trials. Those studies found people who took the medication had significantly reduced blood pressure and rates of control over hypertension compared with dual therapy and placebo, according to George Medicines, which makes Widaplik.
Widaplik is currently being investigated for the prevention of stroke in patients who have had an intracerebral hemorrhage, the company said.
'Single pill combination antihypertensive therapy has great potential to improve hypertension control in the US and worldwide,' said Paul Whelton, MD, MSc, the how Chwan Health System Endowed Chair in Global Public Health at Tulane University, in New Orleans, in a statement about the approval. 'Most patients with hypertension need multiple therapies to achieve their blood pressure goals. The new dose options available with Widaplik offer a treatment regimen that could benefit a broad range of patients, including those just starting treatment.'
Nearly half the adults in the US have hypertension, but only about 1 in 4 have their blood pressure under control. A major risk factor for coronary heart disease, stroke, and heart failure, hypertension is estimated to cause 460,000 deaths in the US each year.
