US FDA Authorize UCB’s Fintepla to Treat Rare Epilepsy in Children

The Food and Drug Administration (FDA) of the United States has now authorized Fintepla (fenfluramine) oral solution CIV developed by UCB for the purpose of treating the children above two years of age who are having seizures associated with Lennox-Gastaut Syndrome (LGS), which has been a rare form of epilepsy during the childhood.

The regulator has also granted the paediatric exclusivity for the prescribed medication, and it had been previously approved by the US FDA and European Commission for the purpose of treating the seizures related to Dravet syndrome in the children aged for two years and above.

This new drug has currently been under the regulatory review along with the PMDA in the country of Japan for the same indication, and the UCB has also stated that, the drug ‘Fintepla’ for the LGS has been available in the United States through a restricted disrupyion programme, which is known as the Risk Evaluation and Mitigation Strategy (REMS) Program.

Mike Davis, epilepsy at UCB said that, the approval of the Fintepla for the Lennox-Gastaut syndrome has been highlighting their continued commitment for the purpose of bringing the differentiated medicines to the patients, who might not be well controlled on the current therapies along with their caregivers.

He also said that, they are very proud for adding the drug as a treatment for the Dravet syndrome to the portfolio of the epilepsy medicines for the purpose of helping them to decrease the impact and burden of the seizures.