U.S. FDA approves UCB’s drug for rare childhood epilepsy

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoRegister now for FREE unlimited access to Reuters.comMarch 28 (Reuters) – UCB SA (UCB.BR) said on Monday the U.S. Food and Drug Administration (FDA) approved its drug to treat seizures associated with Lennox-Gastaut Syndrome (LGS), a rare form of childhood epilepsy.The drug, branded as Fintepla, already has U.S. approval to treat another form of childhood-onset epilepsy, called Davet Syndrome (DS), in patients aged two years and older.LGS causes cognitive dysfunction and frequent seizures that often lead to injury, and UCB’s Zogenix unit estimates that about 30,000 to 50,000 people have LGS in the United States.Register now for FREE unlimited access to Reuters.comBernstein analyst Wimal Kapadia forecast worldwide peak sales for Fintepla of about $300 million by 2030 from the LGS indication alone, and of about $800 million in total from both the indications.Fintepla adjusts a receptor called Sigma 1, which controls how brain cells communicate with each other.The drug comes with a boxed warning for heart and lung conditions such as valvular heart disease and pulmonary arterial hypertension.Register now for FREE unlimited access to Reuters.comReporting by Bhanvi Satija, Manojna Maddipatla and Ann Maria Shibu in Bengaluru; Editing by Devika Syamnath, Sherry Jacob-Phillips and Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.