Accord Healthcare's Dabigatran Etexilate Accord Receives Final Marketing Authorization from EMA in Europe
EMA Grants Final Approval for Dabigatran Etexilate Accord in Europe
The European Medicines Agency (EMA) granted final approval for Accord Healthcare's Dabigatran Etexilate Accord on May 26, 2023. This drug has demonstrated bioequivalence to the original drug, Pradaxa from Boehringer Ingelheim, and has been approved as a generic medicine for the prevention of stroke in adult patients with non-valvular atrial fibrillation (NVAF) and for the treatment and prevention of venous thromboembolism (VTE). It will be supplied to the European market.
Inherits Strong Clinical Evidence of Original Drug, Pradaxa
This generic approval is based on the large-scale clinical data from the RE-LY study of the original Dabigatran Etexilate. In this study, the 150mg Dabigatran group demonstrated a 34% reduction in the risk of stroke and systemic embolism compared to warfarin (Hazard Ratio 0.66, p<0.001). As a direct thrombin inhibitor, it directly blocks thrombin (Factor IIa), inheriting the clinical convenience of NOACs (Novel Oral Anticoagulants) that do not require regular blood tests for monitoring.
Fierce Competition in the Global Anticoagulant Market
The global anticoagulant market, including Europe, is estimated to be worth approximately $37 billion to $49 billion by 2025 and is growing rapidly due to the aging population and the increase in cardiovascular diseases. Dabigatran is a strong competitor in the market, competing fiercely for market share with Factor Xa inhibitors such as Apixaban (Eliquis) and Rivaroxaban (Xarelto). The introduction of this generic is expected to provide affordable treatment options, reduce the burden on healthcare finances, and significantly improve patient access to medication.
Market Penetration and National Reimbursement Barriers Following Generic Launch
In order to enter the European market, it is necessary to overcome the barriers of price negotiations with the health authorities of each member state and listing in the health insurance reimbursement system after EMA approval. Generic drugs are usually priced lower than the original drugs, which is preferred by the financial authorities of each country, but due to differences in national drug pricing policies, it may take some time before they are actually prescribed. Accord Healthcare plans to secure market share quickly by leveraging its price competitiveness through a distribution network established throughout Europe.
Differentiated Indication Expanded to Pediatric Patients
Dabigatran Etexilate Accord has secured an indication for the treatment and prevention of venous thromboembolism (VTE) in pediatric patients as well as adult patients, which will address the unmet needs in the pediatric field. Existing treatments for pediatric venous thromboembolism relied on low molecular weight heparin, which required frequent injections and monitoring, causing pain for both the child and the caregiver. The approval of a convenient oral generic treatment is expected to change the paradigm of pediatric thrombosis management and provide a differentiated competitive advantage in the market.
The European approval of Dabigatran Etexilate Accord marks a short-term catalyst for intensifying generic competition in the approximately $1.3 billion direct thrombin inhibitor market, which was the 2023 revenue of the original Pradaxa. In the medium to long term, it is expected to reshape the market share structure by countering the monopoly of competitors in the Factor Xa inhibitor class, such as Apixaban and Rivaroxaban, in the global anticoagulant market, which is estimated to reach up to $49 billion by 2025, through low-price offensives. This drug, which has already reached the approved and marketed stages, has secured prescription reliability based on solid clinical data from the RE-LY study, which showed a 34% reduction in stroke risk compared to warfarin. From the perspective of researchers and industry professionals, the expansion of the indication to oral treatment for pediatric venous thromboembolism will be a milestone in promoting changes in pediatric thrombosis treatment guidelines.