Six novel meds recommended for approval by EMA/CHMP

28 April 2023

The European medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its April 2023 meeting.

The CHMP recommended granting a marketing authorization for UK pharma major GSK’s (LSE: GSK) Arexvy (recombinant, adjuvanted), the first vaccine for active immunization to protect adults aged 60 years and older against lower respiratory tract disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild, cold-like symptoms that can be serious in vulnerable people, including older adults and those with lung or heart disease and diabetes.

The Committee gave a positive opinion for US pharma major Bristol Myers Squibb’s (NYSE: BMY) Camzyos (mavacamten), for the treatment of symptomatic obstructive hypertrophic cardiomyopathy, a disease in which the heart muscle becomes thickened and can make it harder for the heart to pump blood.

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