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Amgen and UCB’s Evenity recommended by NICE for severe osteoporosis

In the UK, almost four million people are affected by osteoporosis, resulting in around 520,000 fragility fractures each year


Amgen and UCB’s Evenity (romosozumab) has been recommended for use by the NHS in England and Wales by the National Institute for Health and Care Excellence (NICE).

The drug can be used to treat patients with severe osteoporosis who have gone through the menopause and who have a high risk of fractures.

Patients who have had a major osteoporotic fracture within two years could be at risk of another fracture.

NICE’s recommendation makes Evenity the first treatment option for severe osteoporosis since 2010 and could help prevent people who are at high risk of fracture from having to make multiple hospital visits.

In the UK, osteoporosis affects almost four million people, leading to around 520,000 fractures each year, one of the highest rates in Europe.

Postmenopausal women are disproportionately impacted by the condition and have a 50% chance of experiencing an osteoporosis-related fracture during their lifetime. A fifth of women in the UK who have broken a bone are likely to break three bones or more before receiving an osteoporosis diagnosis.

Evenity is a dual-acting humanised monoclonal antibody, given as an injection, twice a month. It binds to and inhibits sclerostin to increase bone formation and decrease bone loss. The dual effect produces rapid increases in bone mass and improvements in bone strength and structure.

In 2020, the treatment was given a marketing authorisation by the UK Medicines and Healthcare products Regulatory Agency (MHRA). It was then made available to patients in Scotland in November 2020, following acceptance from the Scottish Medicines Consortium (SMC). Northern Ireland then followed and approved Evenity in January 2021.

“NICE’s recommendation demonstrates its recognition of the burden of fragility fractures. In the Women’s Health Strategy Vision, Public Health England has recognised the need for greater support for women living with long-term conditions such as osteoporosis,” said Claire Brading, general manager, UCB UK and Ireland.

She added: “After 15 years of research and development, we are pleased that patients in England and Wales will be able to access the latest osteoporosis treatment, and we hope this new treatment contributes to easing NHS pressures.”

Article by
Fleur Jeffries

1st April 2022

From: Regulatory



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