The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Mavacamten a marketing licence. This is the final step in the process of making the drug available as another regulator, The National Institute for Health and Care Excellence (NICE) has already decided to recommend that it is used in the NHS.
Mavacamten, will be known as Camzyos, and over the next few months, hospitals will be working to put systems in place to order sufficient supplies and ensure that they can closely monitor those who are taking the drug.
Once systems are up and running, people who are struggling with their obstructive HCM despite trying the currently recommended drugs, or people for whom existing drugs are not appropriate, should start to receive this new treatment.
Mavacamten will be initially only available in England, Wales and Northern Ireland. We expect that the Scottish Medicines Consortium (SMC) will meet later this year to consider whether the drug should be made available in Scotland.
Laura Kelly, who shared her own experience of living with obstructive HCM with the NICE committee that reviewed Mavacamten, said:
"I used to live life to the full. I was fit, active and having fun. But Obstructive HCM robbed me of my previous life. Having a chance to share my story was really important to me. I wanted people to see the real-life impact of obstructive HCM, what it has done to me and to my family. The decision to recommend Mavacamten is just fantastic news, and I am delighted to have played a part in it."
Cardiomyopathy UK CEO Joel Rose said:
"this is a significant step forward for the cardiomyopathy community. Cardiomyopathy has a huge impact on peoples’ physical and mental health, making day to day living a real struggle. Mavacamten has proven to be effective in relieving symptoms for people with obstructive HCM and we hope that it is the first of many new and effective treatments for people with all forms of cardiomyopathy."
All documents relating to NICE's appraisal of Mavacamten can be found here
Over the last year, we gathered the experience of living with obstructive HCM through our national survey, special focus groups, and from our helpline. This meant that when we presented our evidence to NICE, we were able to give an honest account of the impact that obstructive HCM has on an individual’s physical and mental health as well as the strain it can put on the whole family. We were able to “put a face on the condition” and show the difference that Mavacamten could make. We also spoke to Bristol Myers Squibb about the importance of making the drug affordable to the NHS.
As new treatments are being developed the charity will continue to work with NICE, the SMC (the regulator in Scotland) and pharmaceutical companies to help them understand the experience of living with cardiomyopathy and to promote the development and use of effective and affordable treatment options.