Romosozumab

Romosozumab is a monoclonal antibody designed for the treatment of osteoporosis. It functions by inhibiting the protein sclerostin, and has a dual effect of increasing bone formation and decreasing bone resorption.

History

Romosozumab was developed by the biopharmaceutical companies Amgen and UCB. The drug was approved by the FDA in April 2019 under the brand name Evenity. It was also approved by the EMA in December 2019.

Mechanism of Action

Romosozumab works by binding to sclerostin, a protein that inhibits bone formation. By inhibiting sclerostin, romosozumab allows for increased bone formation. Additionally, the drug also decreases bone resorption, the process by which osteoclasts break down bone and release the minerals, resulting in a transfer of calcium from bone fluid to the blood.

Clinical Trials

Romosozumab has undergone several clinical trials to assess its safety and efficacy. The FRAME study, published in 2016, found that romosozumab significantly reduced the risk of vertebral fractures in postmenopausal women with osteoporosis. The ARCH study, published in 2017, found that romosozumab was superior to alendronate in reducing the risk of fractures.

Side Effects

Common side effects of romosozumab include joint pain, headache, and injection site reactions. Serious side effects may include hypocalcemia, osteonecrosis of the jaw, and atypical femoral fractures.

See Also

• Monoclonal antibodies
• Osteoporosis
• Sclerostin
• Clinical trials