June 6, 2023 Source: drugdu 241
Paul Schloesser
Associate Editor
Bristol Myers Squibb’s heart drug Camzyos has been recommended by the National Institute for Health and Care Excellence as the medication inches closer to approval in the UK and Europe.
In final draft guidance released Friday, NICE recommended mavacamten (branded as Camzyos) as an add-on to standard care for symptomatic obstructive hypertrophic cardiomyopathy.
Obstructive HCM is a heart condition that occurs when part of the muscular wall in the heart becomes thicker, which can then reduce blood supply to the rest of the body.
NICE recommended the drug for several reasons. While the standard care for the disease treats symptoms, the organization said Camzyos is the first to treat oHCM, as compared with beta blockers, certain calcium channel blockers or disopyramide. Some of those treatments have side effects and are not always effective, the organization said.
“We’re therefore pleased to be able to recommend a treatment that has the potential to alter the course of obstructive hypertrophic cardiomyopathy and offer greater hope to people with it,” Helen Knight, NICE’s director of medicines evaluation, said in a news release.
The NICE recommendation follows an FDA approval of Camzyos last year, and pending decisions in the UK and Europe. Bristol Myers told Endpoints News that an application for approval in the UK is underway, and the EMA gave Camzyos a positive opinion back in April, recommending that it be granted marketing authorization.
“This draft guidance from NICE brings us one step closer to potentially bringing this new first-in-class cardiac myosin inhibitor that targets the underlying cause of the disease, to eligible patients in the UK,” Scott Cooke, Bristol Myers Squibb’s general manager in the UK and Ireland, said in an email.
Bristol Myers celebrates a big win with FDA approval of $13B cardio drug mavacamten
The drug generated $24 million in sales in 2022. However, Bristol Myers execs said earlier this year they anticipate up to $4 billion in sales from the drug by 2030.
Bristol Myers spent $13 billion in 2020 to buy MyoKardia, the drug’s original developer.
Reference: https://endpts.com/
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