Bringing a more effective BP therapy to the U.S. market, the FDA approved George Medicines’ triple therapy polypill called Widaplik for patients with hypertension, making it the first of its kind to go to market in the U.S.
- The AHA estimates that more than 122M adults have high blood pressure in the U.S., and nearly 40% aren’t aware of it.
- George’s Widaplik contains the ARB telmisartan, calcium-channel blocker amlodipine, and diuretic indapamide, combining the three for effective BP management.
- This makes Widaplik the first triple combination medication approved by the FDA as an initial treatment for patients who need multiple medications to lower BP.
Widaplik’s approval stems from two studies, including one comparing the polypill against placebo as an initial treatment in patients with hypertension and another comparing the polypill against combinations of two-out-of-three drugs that make up Widaplik.
- In both studies, the polypill resulted in significant and clinically meaningful improvements in blood pressure.
- Those benefits stem both from the three pronged approach to lowering BP, and the reduced medication fatigue and better adherence thanks to only having to take one pill.
- While generally safe across testing, Widaplik’s product label includes an FDA warning for pregnant patients, as the ARB, telmisartan, may cause birth defects.
Further encouraging the BP shift to polypills, a 2023 meta-analysis also found that polypills with three or four combined antihypertensives were significantly better at lowering BP than monotherapy, usual care, or placebo.
- While current guidelines recommend starting with one or two antihypertensives, this requires patients to make frequent visits over several months to get the dose right.
- George’s fixed-dose combination pills containing low doses of three BP-lowering medications now help simplify this process and improve adherence.
The Takeaway
The research over the last couple years has strongly supported the polypill approach when it comes to BP, and the FDA’s approval of George’s Widaplik is an acknowledgement of that. While hypertension remains prevalent in the U.S., Widaplik could become part of the push towards simplifying the condition’s treatment and management.
