Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis. It has been found to decrease the risk of fractures of the spine. Common side effect include headache, joint pain, and pain at the site of injection. It may increase the risk of

heart attack A myocardial infarction (MI), commonly known as a heart attack, occurs when blood flow decreases or stops to the coronary artery of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which m ...

s, strokes, and deaths from cardiovascular disease. It is a humanized monoclonal antibody that targets

sclerostin Sclerostin is a protein that in humans is encoded by the ''SOST'' gene. Sclerostin is a secreted glycoprotein with a C-terminal cysteine knot-like (CTCK) domain and sequence similarity to the DAN (differential screening-selected gene aberrati ...

. Research shows the drug increases bone formation and decreases bone resorption in postmenopausal women with low bone density. Romosozumab was approved for medical use in Japan, the United States and the European Union in 2019. The U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a pharmaceutical that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medica ...

Medical uses

Romosozumab is used for osteoporosis to decrease the risk of fractures. Two trials found that it reduced the rate of vertebral fracture. In one, there was a 73% lower risk of vertebral fracture after one year, and the benefit was maintained after a second year of taking denosumab. In the other, one year of romosozumab followed by one year of alendronate had a 50% vertebral fracture reduction compared to two years of alendronate.

Side effects

Common side effects include headache, joint pain, and pain at the site of injection. In one trial, more patients in the romosozumab group had serious cardiovascular events compared to the alendronate group (0.8% vs 0.3%), though this was not found in a trial of romosozumab vs placebo. Currently, the drug contains a

boxed warning In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it ...

on its labeling stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year.

History

Romosozumab was approved for medical use in Japan in January 2019, the United States in April 2019 and the European Union in December 2019. It was originally discovered by Chiroscience, which was acquired by Celltech (now owned by UCB). Celltech entered in a partnership with

Amgen Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, Amgen was established in ...

in 2002 for the product's development. UK's

NICE Nice ( , ; Niçard: , classical norm, or , nonstandard, ; it, Nizza ; lij, Nissa; grc, Νίκαια; la, Nicaea) is the prefecture of the Alpes-Maritimes department in France. The Nice agglomeration extends far beyond the administrative c ...

provisionally decided not to recommend Romosozumab for use in England and Wales.''NHS medics call for osteoporosis drug to be recommended in England and Wales''
/ref>

References

External links

* * {{Portal bar , Medicine Amgen Monoclonal antibodies