Romosozumab, sold under the brand name Evenity ( or with the pin-pen merger, ), 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 more porous bone, and consequent increase in Bone fracture, fracture risk. It is the most common reason f ...

. It has been found to decrease the risk of fractures of the spine. Common side effects include headache, joint pain, and

injection site reaction Injection site reactions (ISRs) are reactions that occur at the site of injection of a drug. They may be mild or severe and may or may not require medical intervention. Some reactions may appear immediately after injection, and some may be delayed ...

s including pain. It may increase the risk of

heart attack A myocardial infarction (MI), commonly known as a heart attack, occurs when Ischemia, blood flow decreases or stops in one of the coronary arteries of the heart, causing infarction (tissue death) to the heart muscle. The most common symptom ...

stroke Stroke is a medical condition in which poor cerebral circulation, blood flow to a part of the brain causes cell death. There are two main types of stroke: brain ischemia, ischemic, due to lack of blood flow, and intracranial hemorrhage, hemor ...

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. It is a secreted glycoprotein with a C-terminal cysteine knot-like (CTCK) domain and sequence similarity to the DAN (differential screening-selected gene aberrative in neu ...

. 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 US

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 respo ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a prototype drug 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 medic ...

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, sold under the brand name Prolia among others, is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastasis, metastases to bone, and giant cell tumor of bone. The most common side ef ...

. 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 supplementa ...

had a 50% vertebral fracture reduction compared to two years of alendronate.

Side effects

Common side effects include headache, joint pain, and

s including pain. 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 FDA

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

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. Such a limitation does not exist in Japan. In a large real-world study, prescription of romosozumab was associated with less adverse cardiovascular events compared to other osteoanabolic therapies.

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 Corporation, company headquartered in Thousand Oaks, California. As one of the world's largest independent biotechnology companies, Amgen has a ...

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

National Institute for Health and Care Excellence The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care (United Kingdom), Department of Health and Social Care. As the national health technolog ...

(NICE) decided to recommend romosozumab for use in England and Wales.

References

{{Authority control Amgen Monoclonal antibodies Osteoporosis drugs