UCB's Vimpat syrup recalled in EU due to batch defect

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has agreed to a recall of Vimpat 15mg/ml syrup, marketed by Belgian drugmaker UCB (Euronext Brussels: UCB) because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup. Doctors are advised to contact their patients to switch them to Vimpat film coated tablets whenever possible.

UCB is currently preparing the submission of an application for a 10mg/ml syrup for Vimpat to continue to make the medicine available in a liquid formulation. Until this new formulation is authorized in the European Union, another 10mg/ml liquid formulation, which is currently approved in the USA, may be made available on a named patient basis for those patients who cannot take Vimpat tablets.

Vimpat, which last year generated sales of 133 million euros ($188 million), is used to treat partial-onset seizures (epileptic fits starting from one specific part of the brain) as an add-on to other antiepileptic medicines in patients with epilepsy aged 16 years and older. The EMA was informed by UCB that a flake-like precipitate was observed in bottles of Vimpat 15mg/ml syrup. The precipitate consists of the active substance lacosamide and is not a contamination.