Key Approval Highlights

On May 31, 2023, the European Commission approved Lacosamide Adroiq from Extrovis EU Ltd. This followed the positive opinion adopted by the CHMP, under the EMA, on March 30, 2023. The approval signifies a transition from the development stage to a marketable product. Adroiq is a generic version of the original Vimpat, offering a cost-effective alternative for patients requiring lacosamide, including intravenous formulations.

Drug and Patient Population

The generic name for Lacosamide Adroiq is lacosamide, which targets voltage-gated sodium channels. It enhances the slow inactivation of these channels, stabilizing hyperexcitable neuronal membranes. It is indicated for the treatment of partial-onset seizures in patients aged two years and older, both as monotherapy and adjunctive therapy, and as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged four years and older. According to EU data, there are at least 6 million epilepsy patients in Europe, and approximately 70% of them can achieve seizure remission with appropriate antiepileptic medication. Therefore, factors such as supply stability, hospital procurement prices, and the speed of generic adoption are more critical than clinical differentiation in determining patient access.

Regulatory Landscape and Competition

The original Vimpat is owned by UCB and was approved by the EMA on August 29, 2008, by the FDA on October 28, 2008, and by the Japanese Ministry of Health, Labour and Welfare (PMDA) on August 31, 2016. Adroiq is not a new drug that has demonstrated superiority through new clinical trials; instead, it is a generic approved based on its equivalence to the original. Key competitors include levetiracetam (Keppra), lamotrigine (Lamictal), carbamazepine (Tegretol), and eslicarbazepine (Zebinix). In the case of refractory partial-onset seizures, cenobamate (Ontozry) is also a competitor. Due to the potential for QT interval prolongation, caution is advised when prescribing lacosamide in patients with cardiac conduction disorders or when used in combination with other sodium channel blockers.

Market and Commercial Prospects

The European market for epilepsy treatments was valued at approximately USD 1.94 billion in 2022. UCB's global sales of Vimpat decreased from EUR 1.55 billion in 2021 (before the loss of patent exclusivity) to EUR 679 million in 2022 and EUR 411 million in 2023. Generic competition in Europe began in September 2022. The approval of Adroiq is not about creating a new market but rather about shifting brand sales to generics. Extrovis's success will depend on factors such as securing reimbursement in individual countries, winning tenders, establishing distribution networks, and ensuring a reliable supply of intravenous formulations.