MHRA Approves Acoramidis for Treatment of a Heart Condition
Patients suffering from transthyretin amyloid cardiomyopathy (ATTR-CM) now have new hope, as the Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to acoramidis (branded as Beyonttra).
This approval follows a fast-track process, closely aligned with a positive recommendation earlier this year from the European Medicines Agency (EMA).
ATTR-CM is a serious and progressive condition caused when the transthyretin (TTR) protein misfolds, leading to the build-up of amyloid deposits in the heart. These deposits cause the heart muscle to stiffen, impairing its ability to pump effectively.
Acoramidis hydrochloride, the active ingredient in Beyonttra, works by stabilising the TTR protein, slowing the disease’s progression and helping to preserve heart function.
The green light from the MHRA was supported by a robust phase 3 international clinical study involving 632 patients. Results showed that acoramidis was significantly more effective than placebo in slowing heart damage, with participants experiencing a 77% higher chance of benefit regarding mortality rates and cardiovascular hospitalisations over a 30-month period.
The trial also recorded improvements in patients’ quality of life, stabilisation of TTR levels, and other important cardiac markers. Common side effects observed during the study included diarrhoea and gout, with the MHRA confirming that ongoing monitoring of the drug’s safety will continue.
Highlighting the importance of the approval, the MHRA’s Interim Executive Director for Healthcare Quality and Access stated that keeping patients safe and enabling their access to high-quality, safe, and effective medical products remains one of their top priorities.
Furthermore, they emphasised that the approval of acoramidis reflects the agency’s commitment to providing faster access to medicines that have demonstrated safety, quality, and efficacy – and have been recognised by comparable international regulators.
In the United Kingdom, ATTR-CM affects an estimated 600 people with the wild-type form, mainly older men, and approximately 200 with the hereditary form. For many, treatment options have been limited, making this regulatory milestone all the more significant.
In conclusion
The approval of Beyonttra by the MHRA represents a major step forward for patients battling ATTR-CM.
Through strong clinical evidence, international collaboration, and a patient-focused approach, this decision brings a new treatment option to those living with a challenging and life-limiting condition, offering real promise for a better quality of life and improved outcomes.
News Credits: Acoramidis approved for heart condition treatment
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