MHRA extends UCB’s therapy for the treatment of partial-onset seizures.
UCB has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a label extension for seizure treatment, Briviact – also known as brivaracetam. The conclusion arrived after pioneering, group-specific data was used during the decision-making process.
Briviact is used as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in patients from two to four years of age in Britain.
The MHRA decision follows the existing European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approval.
Vital data demonstrated the safety and efficacy of Briviact in the specific paediatric population of two to four-year-old children. Indeed, the principle of extrapolating clinical data from well-controlled studies has been recognised by EMA as potentially addressing the challenge of limited paediatric data availability.
As a result, antiseizure medications which have previously been approved for treating adults with epilepsy, are becoming available to paediatric epilepsy patients. UCB has embraced these guidelines, addressing a significant need for this patient population.
Claire Brading, neurology head, UCB UK, was optimistic about the impact Briviact can make: “We are committed to improving the lives of everyone living with epilepsy and we are delighted with this approval. This extension is positive news for these children living with epilepsy in England, Scotland and Wales, opening up new adjunctive treatment options to support the management of their seizures.”
Epilepsy is a common neurological condition worldwide and affects approximately 50 million people.