Viatris' 'Eltrombopag Viatris' Receives EMA Approval in Europe, Poised to Enter the $4 Billion ITP Market
European EMA Approval and Market Access
The European Medicines Agency (EMA) granted final approval for Viatris' Eltrombopag Viatris on December 12, 2024. This drug is the first generic version of Novartis' blockbuster treatment, Revolade, signaling the start of intensified price competition in the European market following patent expiration. It is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adults and children aged one year and older, and thrombocytopenia in patients with chronic hepatitis C. This approval was expedited based on data demonstrating bioequivalence to the original drug and is expected to significantly improve treatment access for European patients.
Differentiated Convenience of Oral TPO-RA
Eltrombopag Viatris is an oral treatment that stimulates platelet production through the thrombopoietin receptor agonist (TPO-RA) mechanism. The main competing drug, Romiplostim (Nplate) from Amgen, requires weekly visits to a hospital for subcutaneous (SC) injections. In contrast, Eltrombopag Viatris is an oral tablet that can be taken once daily at home, offering significant advantages in terms of patient convenience and quality of life. This ease of administration reduces hospital visit costs and improves long-term treatment adherence, thereby alleviating the financial burden on patients and the healthcare system.
Entry into the Blockbuster Generic Market and Market Restructuring
The original drug, Revolade, recorded global sales of approximately $2.216 billion in 2024. However, with the activation of generic competition starting in 2025, Novartis' sales are projected to decline sharply to $1.636 billion. Through this EMA approval, Viatris aims to rapidly expand its market share in the European ITP market, which is estimated at $3.3 billion to $4 billion, by offering a more affordable price compared to the original drug. The emergence of a competitively priced generic is expected to disrupt the existing market and provide a strong basis for favorable drug price negotiations with health authorities.
European Health Authorities' Drug Price Negotiations and Future Challenges
The European market operates different public healthcare insurance systems in each country, making the reimbursement listing process after approval a key factor for market success. Viatris prioritizes close negotiations with European health authorities, who seek price reductions, to ensure early inclusion in prescription lists. Given the European market's emphasis on promoting generic prescriptions, initial marketing and securing distribution channels will be crucial for success. As real-world data (RWD) accumulates, clinical guidelines may increasingly recommend the preferential use of generics, which is expected to contribute to Viatris' revenue diversification.
This EMA approval for Eltrombopag Viatris generic represents a significant opportunity for Viatris to capture new market share in the approximately $4 billion global ITP treatment market, leveraging its strong price competitiveness. Approved in time for the patent expiration of Revolade, which generated over $2.2 billion in sales in 2024, this approval is expected to drive Viatris' medium- to long-term revenue growth. With its convenient oral administration compared to Amgen's Nplate (subcutaneous injection), and a lower price than the original drug, Eltrombopag Viatris is well-positioned to penetrate the market rapidly, aligning with European governments' focus on reducing drug costs. From a clinical and research perspective, the availability of a bioequivalent alternative treatment option is expected to improve treatment adherence and address unmet needs, leading to positive outcomes for patients. As a result, Viatris is expected to quickly penetrate the existing market and generate hundreds of millions of dollars in new generic revenue annually through improved negotiating power and the collection of real-world data.