FDA Approves Polypill Widaplik for Hypertension

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The U.S. Food and Drug Administration has approved Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults.

The combination pill is the first and only FDA-approved triple combination medication for use as an initial therapy in patients who will likely need multiple drugs to achieve their ideal blood pressure numbers. The pill is available in a standard dose, as well as two low doses, and can be used in those initiating treatment.

The FDA approval is based on positive results from two international phase 3 trials that compared Widaplik to dual combinations of its component drugs as well as to placebo. The results of both trials indicated that Widaplik significantly improved blood pressure control compared with the comparators.

The most common adverse event reported in patients treated with Widaplik was symptomatic low blood pressure. Additionally, Widaplik is contraindicated in patients with anuria or known hypersensitivity to other sulfonamide-derived drugs. Widaplik is not to be coadministered with aliskiren in patients with diabetes, and a boxed warning indicates discontinuation of Widaplik during pregnancy.

“I am very excited and pleased to have Widaplik approved for the treatment of hypertension in the U.S. Single-pill combination antihypertensive therapy has great potential to improve hypertension control in the U.S. and worldwide,” Paul Whelton, M.D., of Tulane University in New Orleans and past president of the World Hypertension League, said in a statement. “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 granted to George Medicines.

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Source: HealthDay

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