BRIEF—FDA new use indication for UCB's Vimpat CV

6 November 2017

Today, the US Food and Drug Administration approved a label extension of UCB’s anti-epilepsy drug Vimpat CV (lacosamide) as an oral option for patients four years and older with partial-onset seizures (POS).

The approval provides neurologists and others with a proven treatment option that offers administration flexibility (tablet or oral solution) that can be especially helpful for treating pediatric patients, says UCB, Belgium’s largest pharma company.

Pediatric epilepsy is the most common, serious, treatable neurological disorder among children and young adults, affecting about 470,000 children in the USA alone.

Still, as many as 20% of these patients report inadequate seizure control, affecting overall health as well as quality of life, leading to poor psychosocial health outcomes such as low self-esteem, worry, negative feelings about life, depression and anxiety.

Children with inadequate seizure control also often experience social stigma, which makes safe and effective treatment options like Vimpat have far-reaching implications.

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