Introduction to EVENITY
EVENITY, also known as romosozumab, is a biologic drug developed by Amgen and UCB for the treatment of osteoporosis in postmenopausal women at high risk of fracture. This drug has been making significant waves in the healthcare industry due to its innovative mechanism of action and promising clinical outcomes.
Mechanism of Action and Clinical Benefits
EVENITY works by both stimulating bone formation and decreasing bone resorption, offering a dual benefit that sets it apart from other osteoporosis treatments. This unique mechanism has been shown to significantly increase bone mineral density (BMD) and reduce the risk of fractures in postmenopausal women with osteoporosis[1][4].
Market Size and Growth Projections
The osteoporosis market, driven in part by drugs like EVENITY, is expected to grow substantially. The global osteoporosis market size was valued at USD 10.2 billion in 2023 and is projected to reach USD 14.8 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 3.49% during the forecast period from 2024 to 2034[1].
Sales Performance of EVENITY
EVENITY has shown robust sales growth since its launch. In the first quarter of 2024, EVENITY sales increased by 35% year-over-year to $342 million, primarily driven by volume growth. For the full year 2022, EVENITY sales increased by 48% year-over-year, reaching a record $225 million in the fourth quarter[2][5].
Global Reach and Market Penetration
EVENITY has been successfully launched globally by Amgen, Astellas, and UCB since 2019. The drug has reached over 600,000 women living with postmenopausal osteoporosis at high risk of fracture. Net sales of EVENITY outside Europe are reported by the partner companies, and the drug has annualized worldwide sales of more than US$ 1 billion[3].
Regulatory Updates and Challenges
Despite its success, EVENITY faced a regulatory setback in the European Union. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the Marketing Authorisation Application for EVENITY. However, Amgen and UCB intend to submit a written notice for a re-examination by the CHMP, highlighting their belief in the drug's positive benefit-risk profile[4].
Competitive Landscape
The osteoporosis market is highly competitive, with several leading pharmaceutical companies, including Amgen, AbbVie, and Roche, at the forefront of developing innovative treatments. Amgen’s Prolia (denosumab) and EVENITY (romosozumab) are particularly notable for their impact on the treatment landscape, offering advanced therapeutic options for osteoporosis management[1].
Financial Impact on Amgen and UCB
For Amgen, the success of EVENITY has contributed significantly to its financial performance. The company's non-GAAP operating income increased from $2.8 billion to $3.1 billion in the first quarter of 2024, despite higher operating and interest expenses. UCB also reported strong growth driven by EVENITY, with net sales increasing by 140% and contributing to the company's overall revenue growth[2][3].
Future Growth and Development
Both Amgen and UCB are committed to continued investment in research and development. UCB aims to increase its revenues in 2024, driven by the launches of new products and the solid contributions from its existing portfolio. Amgen continues to focus on areas of high unmet medical need, leveraging its biologics manufacturing expertise to develop innovative therapeutics[3][4].
Challenges and Opportunities
While EVENITY has shown promising results, the market is not without challenges. Factors such as managed care trends, health care cost containment, and reimbursement policies imposed by third-party payers can impact sales. However, the growing awareness and preventative measures for osteoporosis, along with substantial investments in research and development, present significant opportunities for growth[1][4].
Key Markets
The United States is the largest market for osteoporosis treatment, driven by advancements in treatment options, increased awareness, and substantial investment in research and development. Other major markets include Germany, France, the United Kingdom, Italy, Spain, and Japan[1].
Conclusion
EVENITY has established itself as a groundbreaking treatment in the osteoporosis market, driven by its unique mechanism of action and strong clinical outcomes. With robust sales growth, global market penetration, and continued investment in research and development, EVENITY is poised to play a significant role in the future of osteoporosis management.
Key Takeaways
- EVENITY is a biologic drug that stimulates bone formation and decreases bone resorption.
- The drug has shown significant sales growth, with a 35% year-over-year increase in the first quarter of 2024.
- EVENITY has reached over 600,000 women globally since its launch in 2019.
- The osteoporosis market is expected to grow to USD 14.8 billion by 2034.
- Regulatory challenges in the EU are being addressed through re-examination processes.
- Amgen and UCB are committed to continued investment in research and development.
FAQs
What is the mechanism of action of EVENITY?
EVENITY works by both stimulating bone formation and decreasing bone resorption, offering a dual benefit in treating osteoporosis.
How has EVENITY performed in terms of sales?
EVENITY sales increased by 35% year-over-year to $342 million in the first quarter of 2024 and by 48% for the full year 2022.
Which companies are involved in the development and marketing of EVENITY?
EVENITY is co-developed and marketed by Amgen and UCB, with Astellas also involved in its global launch.
What are the regulatory challenges faced by EVENITY in the EU?
The CHMP of the EMA adopted a negative opinion on the Marketing Authorisation Application for EVENITY, but Amgen and UCB are pursuing a re-examination.
What is the projected growth of the osteoporosis market?
The global osteoporosis market is expected to reach USD 14.8 billion by 2034, with a CAGR of 3.49% during the forecast period from 2024 to 2034.
Cited Sources:
- Osteoporosis Market Size to Reach USD 14.8 Billion by ... - BioSpace
- AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS - PR Newswire
- UCB on Growth Path for a Decade Plus - UCB
- UCB and Amgen Provide Regulatory Update on Status of EVENITY ... - UCB
- AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 ... - Amgen
