FDA approves 1st hypertension polypill for initial treatment

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The FDA has approved a polypill as an initial treatment for hypertension in adults for the first time.

Here’s what to know:

1. Widaplik — manufactured by George Medicines — is a polypill that contains telmisartan, amlodipine and indapamide.

2. Historically, monotherapies have been the initial treatment for hypertension. This is the first triple-combination medication to be approved for patients who are likely to need multiple drugs to achieve their blood pressure goals, according to a June 9 company release.

3. In trials, the polypill reduced systolic blood pressure by around 7 to 8 mm Hg versus placebo in people with mild-to-moderate hypertension. It also showed small but significant blood pressure reductions compared to other dual drug combinations.

4. Widaplik is expected to be available in fourth-quarter 2025.

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