Romosozumab, sold under the brand name Evenity, is a medication used to treat

osteoporosis Osteoporosis is a systemic skeletal disorder characterized by low bone mass, micro-architectural deterioration of bone tissue leading to bone fragility, and consequent increase in fracture risk. It is the most common reason for a broken bone ...

. 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 may tr ...

stroke A stroke is a medical condition in which poor blood flow to the brain causes cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. Both cause parts of the brain to stop functionin ...

s, and deaths from cardiovascular disease. It is a

humanized monoclonal antibody Humanized antibodies are antibodies from non-human species whose protein sequences have been modified to increase their similarity to antibody variants produced naturally in humans. The process of "humanization" is usually applied to monoclonal ant ...

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 aberrative ...

. 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 List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(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 medicat ...

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 Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. Denosumab is contraindicated in people with low blood calci ...

. In the other, one year of romosozumab followed by one year of

alendronate Alendronic acid, sold under the brand name Fosamax among others, is a bisphosphonate medication used to treat osteoporosis and Paget's disease of bone. It is taken by mouth. Use is often recommended together with vitamin D, calcium supplementati ...

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

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 Chiroscience Group Plc was a British-based biotech company, founded by Christopher Evans. The company was taken over by Celltech in 1999, which was acquired in 2004 by UCB. History Chiroscience was born from the demise of the company Enzymati ...

, which was acquired by

Celltech Celltech Group plc was a leading British-based biotechnology business based in Slough. It was listed on the London Stock Exchange and was a constituent of the FTSE 100 Index. History Celltech was founded by Gerard Fairtlough in 1980 with fina ...

(now owned by UCB). Celltech entered in a partnership with

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

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