European Commission (EC) has approved marketing a new medicine called “EVENITY® (romosozumab)” to treat extreme osteoporosis symptoms in postmenopausal women. The announcement was made today by Amgen and UCB. This new medicine is specifically designed for women who are at a high risk of bone fracture, due to old age. EVENITY would work on strengthening bone density and reduces the risk of bone loss or resorption.
VP, Research and Development at Amgen, David M. Reese shares that the company is pleased by approval from the European Commission and he hopes to make this medicine available to all women who are in need of something like this. Typically, an older age woman is much likely to experience another fracture within one year of having the first fracture. This risk is even higher for diagnosed patients of osteoporosis. Using a medicine like this would help to re-build the bone density and thus reduces the risk of osteoporosis.
This approval comes after a profoundly positive response fro the Committee for Medicinal Products for Human Use (CHMP) that is documented in the month of October this year. However, the commercial launch of EVENITY in all European Economic Areas (EEA) is set to happen within the first six months of 2020.
When women age, they are more susceptible to get fractures. As per the recent estimates, approximately €37 billion is paid every year on healthcare and medical services for nearly 2.7 million fractures happening in European countries of France, Spain, Germany, Italy, Sweden, and the United Kingdom. In the next 10 years, this expenditure is estimated to cross €47 billion.
Dr. Pascale Richetta from UCB shares that people in Europe are now expecting a better life in older years but the fragility fractures which are typical for osteoporosis patients is a problem in it. These fractures hit one in three osteoporosis diagnosed age women who are over 50. On the other side, there are many women who are never diagnosed or treated with osteoporosis even after getting a fracture.
A fracture is a hurdle to physical movement and also causes mental stress. Overall it affects the quality of health and there must be something which could bring positive changes to these people’s life. Fortunately, this approval of EVENITY would do the good in the life of women living with osteoporosis. It would reduce the chances of a second fracture after getting first. Moreover, it would overall help in fracture prevention.
Alison Doyle serves as head of clinical operations in “Royal Osteoporosis Society” and she adds that it is easy to avoid getting fragility fractures. But this prevention and managing a fracture requires extreme care and expertise which is neglected due to social and economic factors.
This growing number of fractures suggest following a plan of action that contains education, awareness, specialized care, access to medicines and lifestyle changes. So this approval is a positive sign for both osteoporosis patients and the medical professionals working in this area.
This current approval for marketing authorization would be applied in all European countries and EEA-European Free Trade Association (EFTA) states that include Liechtenstein, Iceland, and Norway. Altogether, EVENITY is approved and would be available soon in 37 countries. It would also be available in the USA, Canada, Australia, and Japan in the next six months.