Lennox-Gastaut综合征(LGS)相关性癫痫新药！芬氟拉明已被FDA授予优先审查资格！

Lennox-Gastaut syndrome (LGS) is a rare and devastating lifelong form of childhood epilepsy that can be caused by a number of different causes. LGS is characterized by many different epilepsy types, including many that result in frequent falls and injuries, and these types often do not respond to currently available epilepsy medications. The intellectual and behavioral problems associated with LGS, as well as 24-hour care requirements, add to the complexity of living with this disease. In the United States, an estimated 30,000 to 50,000 people have LGS.

Gail Farfel, Ph.D., executive vice president and chief development officer of Zogenix, said: "For us, the development of FINTEPLA is a very important milestone in the field of LGS and has the potential to provide a new treatment option for this rare and difficult-to-treat childhood developmental and epileptic encephalopathy. We look forward to working closely with the FDA to bring FINTEPLA to the market as soon as possible for the treatment of patients with LGS-related seizures."

The sNDA submission is based on results from an active, global, randomized, placebo-controlled Phase 3 clinical trial (Study 1601) in which FINTEPLA (at a dose of 0.7/mg/kg/day) was superior to placebo in reducing seizure frequency in 263 patients (2-35 years of age); and long-term safety and efficacy data in Zogenix's ongoing open-label extension trial also demonstrated the superiority of FINTEPLA.

In June 2020, FINTEPLA was approved by the FDA for the treatment of seizures associated with Dravet syndrome in patients two years of age and older. Study data showed that FINTEPLA significantly reduced the frequency of monthly convulsive seizures compared with placebo.

References:

https://www.globenewswire.com/news-release/2021/12/01/2344064/0/en/Zogenix-Announces-U-S-FDA-Acceptance-for-Priority-Review-of -Supplemental-New-Drug-Application-for-FINTEPLA-Fenfluramine-for-the-Treatment-of-Seizures-Associated-with-Lennox-Gastaut.html