Laboratoires CTRS' Neofordex, a treatment for multiple myeloma, receives marketing authorization from the European Medicines Agency (EMA)
Official entry into the European market and a new milestone
Neofordex, an adjuvant treatment for multiple myeloma developed by the French rare disease specialist pharmaceutical company Laboratoires CTRS, has received final marketing authorization from the European Medicines Agency (EMA). This approval grants Neofordex the legal right to be commercialized in the 27 countries of the European Union (EU). It is considered an innovative alternative that can alleviate the burden of taking a large number of pills, which patients have experienced with existing standard treatments. This regulatory approval is interpreted as a success that demonstrates the drug's safety and efficacy and establishes a key foothold for market launch.
Improved convenience through a high-dose formulation
The active ingredient in Neofordex, dexamethasone acetate, is a corticosteroid drug that targets glucocorticoid receptors and kills cancer cells. In existing treatments, patients with multiple myeloma had to take dozens of 0.5mg low-dose tablets of Dectancyl, which caused significant discomfort. In contrast, Neofordex allows for the administration of a high dose of 40mg in a single tablet, significantly improving patient compliance. This improved convenience enhances the continuity of anticancer chemotherapy, ultimately contributing to improved treatment outcomes.
Demonstration of bioequivalence and establishment of clinical confidence
This approval is based on a clinical pharmacokinetic study conducted on 24 healthy adult volunteers. In this study, the bioequivalence of Neofordex 40mg (half tablet, 20mg) and the existing comparator drug, Dectancyl 0.5mg (40 tablets), was successfully demonstrated. This is direct evidence that Neofordex is completely identical to existing standard treatments in terms of efficacy and safety. Approved as a hybrid medicine based on a large amount of accumulated academic literature data and clinical evidence, it minimizes safety concerns.
Fierce market competition and commercial prospects
The global market size for multiple myeloma is approximately $31 billion (USD) in 2026 and is growing rapidly. Neofordex is administered in this market in combination with major anticancer drugs such as lenalidomide and bortezomib. Although it must compete with low-cost generic dexamethasone, it plans to target a niche market by emphasizing its unique convenience as a high-dose, single-tablet formulation. In the future, negotiations on drug prices in each European country and the inclusion in health insurance coverage are expected to be key variables for early market penetration.
Neofordex has a commercial advantage in that it can significantly reduce the burden of medication on multiple myeloma patients compared to existing 0.5mg low-dose formulations, thereby improving treatment compliance. In a global multiple myeloma treatment market of approximately $31 billion in 2026, it is approved for use in combination with lenalidomide and bortezomib, ensuring stable demand. Clinical studies have demonstrated bioequivalence with the comparator drug Dectancyl in a study group of 24 subjects, eliminating concerns about efficacy. However, it must compete with low-cost generic dexamethasone products throughout Europe, so rapid inclusion in national health insurance coverage and a differentiated strategy that emphasizes the convenience of the formulation are required to secure long-term profitability.
Source: EMA (ema)