United States: The US Food and Drug Administration (FDA) has granted approval to Widaplik (telmisartan, amlodipine, and indapamide) to be used in treating adult hypertension.
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The combination pill is the first and only FDA-approved triple combination pill to be used as a first line of treatment in patients who are predicted to require more than one drug to attain their optimal numbers in blood pressure.
The pill comes in one regular dose and two low doses, and it can be utilized by individuals who are starting treatment.
The approval was given by the FDA following the beneficial outcomes of two international stage 3 trials, which compared Widaplik with dual mixtures of its constituent drugs and also with placebo.
In both trials, the outcomes showed that Widaplik substantially enhanced blood pressure control in comparison with the comparators.
Symptomatic low blood pressure was the most reported adverse event in patients using Widaplik.
Moreover, Widaplik should not be used by patients who have anuria or those who are hypersensitive to other medicines of the sulfonamide derivatives.
Widaplik should not be coadministered with aliskiren in patients with diabetes, and there is a boxed warning that Widaplik should be discontinued during pregnancy.
According to Paul Whelton, M.D., of Tulane University in New Orleans and past president of the World Hypertension League, “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,” US News reported.
“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,” Whelton reported.