Local start up files for regulatory approval of triple-combination blood pressure therapy

Pharma News: High blood pressure (BP) is a leading contributor to the global disease burden, yet less than one in four treated individuals achieve the recommended BP goals.

In response to this pressing health issue, George Medicines has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for GMRx2, an Australian-developed, novel low-dose triple combination pill (telmisartan/amlodipine/indapamide) for the treatment of hypertension.

Two recent large-scale trials demonstrated the effectiveness of single-pill combination for individuals with hypertension, whether untreated or receiving monotherapy. The trials revealed that these ‘hypertension polypills’ significantly outperformed usual care, achieving over 80% BP control without an increase in withdrawal due to side effects.

Mark Mallon, Chief Executive Officer of George Medicines, emphasised the need for a new approach to combat this leading cause of death and disability.

“GMRx2’s potential to deliver rapid and effective blood pressure control and a favourable tolerability profile, provides an opportunity to transform the management of hypertension.

“We look forward to the outcome of the regulatory process, alongside our ongoing activities to secure commercialisation partners for GMRx2, so that we can bring the value of this important medicine to patients,” Mallon stated.

The World Health Organisation reports that two-thirds of the estimated 1.28 billion adults aged 30-79 with hypertension live in low- and middle-income countries, many of whom are undiagnosed and untreated. A significant challenge in these regions is the limited access to essential medicines for chronic diseases. There is hope that GMRx2 will help address this unmet need.

George Medicines, a venture-backed spin-out company, was initially established to commercialise the research of The George Institute for Global Health. The company leverages the research base and scientific expertise of The George Institute to advance the late-stage development of single-pill, multi-mechanism, combination therapies.

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