George gets FDA nod for first blood pressure triple therapy
George Medicines' chief executive Mark Mallon.
UK start-up George Medicines has brought its triple therapy for high blood pressure over the finish line, with an FDA approval that sets up a launch before the end of this year.
Widaplik (previously known as GMRx2) is a combination of three well-established antihypertensive medicines – telmisartan, amlodipine, and indapamide – and heads a pipeline of medicines at George that are designed to improve therapy adherence in diseases that require patients to take multiple tablets per day.
According to the London-headquartered company, it is the first triple combination to be approved for the initial treatment of hypertension in the US and can help people likely to need multiple drugs to achieve their blood pressure goals. It is now preparing for a commercial launch in the US in the last quarter of 2025.
While high blood pressure is very common, most people with it do not achieve adequate control, mainly due to continued use of low-efficacy regimens, including monotherapy with current drugs. And that is happening even though current treatment guidelines now recommend the use of single-pill dual therapy for most patients and acknowledge the benefit of starting combination therapy as early as possible.
Only around one in five patients treated for hypertension worldwide can manage it effectively with current medicines, and it is well-established that uncontrolled blood pressure raises the risk of serious complications like strokes and early death.
"Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control," said George's chief executive, Mark Mallon, who joined the company last year after a long career at AstraZeneca, NeoGenomics Labs, and Ironwood Pharma.
"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," he added.
The drug has been developed in a standard dose and two lower (quarter- and half-strength) doses to help tailor treatment to patients and balance efficacy with good safety and tolerability.
Data from a phase 3 trial of Widaplik was published in The Lancet last October and showed that the drug was more effective than dual therapy at reducing both home- and clinic-measured blood pressure with both the standard- and half-dose formulations, and also helped more patients meet their blood pressure control targets.
The authors of the paper said that use of the drug "could result in a substantial improvement in blood pressure control in clinical practice."
George Medicines is an independent spin-out company from The George Institute for Global Health, a medical research institute with a focus on addressing global health inequity. After Widaplik, its next pipeline candidate is GMR4, a single-pill triple therapy in development as a first-line treatment for type 2 diabetes.
