FDA Approves Widaplik for Treatment of Hypertension
Widaplik is a single pill combination of telmisartan, amlodipine and indapamide used to lower blood pressure in adult patients.
The FDA approved telmisartan, amlodipine and indapamide (Widaplik) for the treatment of hypertension in adult patients, George Medicines said in a release.1 The therapy, which includes all 3 medications in a single pill, is used to lower blood pressure and can also be used as an initial treatment.
FDA Approves Widaplik for Treatment of Hypertension / Tada Images - stock.adobe.com
Widaplik is available in 3 doses, a standard dose and 2 low doses, allowing it to deliver benefits to patients early in the treatment pathway. The therapy is the first and only triple combination therapy approved by the FDA for use as an initial therapy in patients who will likely need multiple medications to achieve blood pressure goals.
“I am very excited and pleased to have Widaplik approved for the treatment of hypertension in the US,” Paul Whelton, Chair of Global Public Health at Tulane University, said in a release.1 “Single pill combination antihypertensive therapy has great potential to improve hypertension control in the US and worldwide. 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.”
The approval of Widaplik was based on data from 2 phase 3 trials. In the GMRx2_PCT trial (NCT04518306), the efficacy and safety of the therapy was compared to placebo. In the GMRx2_ACT trial (NCT04518293), the efficacy and safety of Widaplik was compared to 3 dual therapies: telmisartan combined with amlodipine, telmisartan combined with indapamide, and amlodipine combined with indapamide.
GMRx2_PCT was an international, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that evaluated the efficacy and safety of Widaplik compared to placebo for the treatment of hypertension in adult patients. The study cohort included 295 patients who received either 1 of 2 doses of Widaplik or placebo. The study found that at week 4, blood pressure control for the first dose of Widaplik was 65% and 70% for the second dose, compared to 37% for placebo.2
GMRx2_ACT was an international, randomized, double-blind, active-controlled phase 2 trial that evaluated the efficacy and safety of Widaplik compared to telmisartan combined with amlodipine, and telmisartan combined with indapamide for the treatment of hypertension in adult patients. The study cohort included 1385 patients who received either Widaplik, telmisartan combined with amlodipine, telmisartan combined with indapamide, or amlodipine combined with indapamide. The study found that at week 12, the mean home systolic blood pressure was 126 mm Hf for the Widaplik group, which was lower than each combination group. The blood pressure control rate with Widaplik was also seen to be superior to each of the combination groups.3
In the release, George Medicines said it anticipates a commercial launch of Widaplik in the US sometime in the fourth quarter. The company also said that it plans to submit the medication for approval to regulatory bodies in other countries later this year.
“Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control,” Mark Mallon, CEO of George Medicines, said in a release.1 “Widaplik can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure. With its triple combination efficacy, established safety profile, good tolerability and its availability in a single pill, WIDAPLIK has the potential to address key challenges in current hypertension treatment approaches.”
READ MORE: Cardiology Resource Center
Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our free Drug Topics newsletter.
