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Home Drug Development FDA Approvals

Beovu, Made By Novartis, Earns A Recommendation From NICE

Content Team by Content Team
2nd August 2022
in FDA Approvals, News
Novartis to acquire The Medicines Company for USD 9.7 bn

Following NICE’s recommendation of a novel therapy alternative for diabetic macular oedema (DMO), thousands of patients could receive transformative care. In the final form of the guidance, brolucizumab, also known as Beovu, is suggested as a treatment for adults with diabetic macular oedema, the primary cause of vision impairment for people having diabetes in the UK.

Over 22,000 people, according to the company’s estimation, could profit from the new therapy in its first year. A disease known as diabetic macular oedema affects the retina and is caused by blood vessels that provide nutrients and oxygen being leaky and damaged as a result of high blood glucose levels in some diabetics.

For the first 5 doses, Beovu, which is manufactured by Novartis, is injected into the eye once every 6 weeks. After that, based on how the condition is responding, specialists determine how frequently the therapy should be given.

Typically, anti-VEGF injections like aflibercept or ranibizumab are used to treat diabetic macular oedema first in order to lessen swelling. Another anti-VEGF injectable that functions similarly to aflibercept is brolucizumab, and data from clinical trials indicates that it is equally as effective. In comparison to aflibercept and ranibizumab, the assessment committee determined that brolucizumab is expected to be less expensive or have comparable prices.

Using the NICE fast-track price comparison appraisal method, the approval process was completed from the invitation to the published recommendations in slightly over five months. This is equivalent to a typical appraisal taking half as long.

When a cost comparison reveals that the novel treatment is expected to offer comparable or higher health benefits at a comparable or lower cost than therapies already suggested in the advice, a fast-track appraisal may be applied. In order to achieve quick, beneficial results like this for patients, NICE collaborates closely with colleagues at NHS England and businesses.

To provide brolucizumab to the NHS with a discreet discount, NHS England has reached a commercial agreement through a straightforward patient access programme.

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