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▎WuXi AppTec Content Team Editor On March 28, 2022, UCB (UCB) announced that the U.
S.
Food and Drug Administration (FDA) has approved the expanded indication of Fintepla (fenfluramine) for the treatment of patients two years of age and older with Lennox- Seizures associated with Gastaut syndrome (LGS)
.
A phase 3 clinical trial demonstrated greater improvement in the Clinical Global Impression Scale (CG-I) in patients with LGS when taking fenfluramine compared to placebo
.
Fenfluramine was developed as an appetite suppressant diet pill in the 1960s and was approved in the United States in 1973
.
However, subsequent studies found that the drug was associated with primary pulmonary hypertension and valvular heart disease in a small number of patients, so it was withdrawn from the market in 1997
.
Previously, Fintepla has been approved to treat seizures associated with Dravet syndrome in patients 2 years of age and older, completing the "old medicine for new life"
.
LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) characterized by a high incidence of drug-refractory seizures and severe impairment of neurodevelopmental, cognitive, and motor function
.
LGS has far-reaching effects beyond seizures, including problems with communication, psychiatric symptoms, sleep, behavioral challenges, and limited mobility
.
In addition, sudden epilepsy death is also a major problem in LGS patients
.
Fintepla is a low-dose fenfluramine in liquid form
.
It may reduce the frequency of seizures by modulating serotonin machinery and sigma-1 receptor activity
.
It has been granted orphan drug designation by the United States and the European Union, and has also been granted breakthrough therapy designation by the US FDA
.
Fenfluramine has been shown to be effective in the most difficult types of seizures to treat, including fall seizures, which cause a person to suddenly lose muscle tone and fall to the ground, with a high risk of injury
.
Fenfluramine's mechanism of action differs from current seizure therapies and can be used without interrupting current antiepileptic regimens
.
The Phase 3 clinical trial enrolled 263 LGS patients (age range: 2-35 years)
.
Trial results showed that the 0.
7 mg/kg dose level of Fintepla significantly reduced the frequency of fall-onset seizures in patients compared with the placebo group (p=0.
0037)
.
Nearly a quarter of patients in the Fintepla group had a ≥50% reduction in seizure frequency; 18% had a 50-75% reduction in seizure frequency; and 6% had a >75% reduction at every 28 days of treatment
.
In terms of safety, common adverse reactions in Fintepla patients (incidence of at least 10% and higher than placebo) were diarrhea, decreased appetite, fatigue, somnolence and vomiting
.
"LGS is one of the most challenging epileptic encephalopathies, and despite multiple antiepileptic drug regimens, the vast majority of patients remain poorly controlled
.
" Kelly, Children's Hospital Colorado Professor Knupp commented, "As a complementary therapy, fenfluramine offers a different mechanism of action and has been shown to significantly reduce the number of seizures associated with falls, which is one of the key measures in the management of this severe form of epilepsy.
.
"Reference: [1] US FDA Approves FINTEPLA® ▼(fenfluramine) Oral Solution for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS).
Retrieved March 28, 2022, from https:// -media/Press-Releases/article/US-FDA-Approves-FINTEPLAR-Vfenfluramine-Oral-Solution-for-Treatment-of-Seizures-Associated-with-Lennox-Gastaut-Syndrome-LGS Disclaimer: WuXi AppTec Content Team Focus on introducing the progress of global biomedical health research
.
This article is only for the purpose of information exchange.
The opinions in this article do not represent WuXi AppTec's position, nor do they support or oppose the views in the article
.
This article is not a treatment plan recommendation
.
If you need to obtain a treatment plan For guidance, please go to a regular hospital for treatment
.
S.
Food and Drug Administration (FDA) has approved the expanded indication of Fintepla (fenfluramine) for the treatment of patients two years of age and older with Lennox- Seizures associated with Gastaut syndrome (LGS)
.
A phase 3 clinical trial demonstrated greater improvement in the Clinical Global Impression Scale (CG-I) in patients with LGS when taking fenfluramine compared to placebo
.
Fenfluramine was developed as an appetite suppressant diet pill in the 1960s and was approved in the United States in 1973
.
However, subsequent studies found that the drug was associated with primary pulmonary hypertension and valvular heart disease in a small number of patients, so it was withdrawn from the market in 1997
.
Previously, Fintepla has been approved to treat seizures associated with Dravet syndrome in patients 2 years of age and older, completing the "old medicine for new life"
.
LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) characterized by a high incidence of drug-refractory seizures and severe impairment of neurodevelopmental, cognitive, and motor function
.
LGS has far-reaching effects beyond seizures, including problems with communication, psychiatric symptoms, sleep, behavioral challenges, and limited mobility
.
In addition, sudden epilepsy death is also a major problem in LGS patients
.
Fintepla is a low-dose fenfluramine in liquid form
.
It may reduce the frequency of seizures by modulating serotonin machinery and sigma-1 receptor activity
.
It has been granted orphan drug designation by the United States and the European Union, and has also been granted breakthrough therapy designation by the US FDA
.
Fenfluramine has been shown to be effective in the most difficult types of seizures to treat, including fall seizures, which cause a person to suddenly lose muscle tone and fall to the ground, with a high risk of injury
.
Fenfluramine's mechanism of action differs from current seizure therapies and can be used without interrupting current antiepileptic regimens
.
The Phase 3 clinical trial enrolled 263 LGS patients (age range: 2-35 years)
.
Trial results showed that the 0.
7 mg/kg dose level of Fintepla significantly reduced the frequency of fall-onset seizures in patients compared with the placebo group (p=0.
0037)
.
Nearly a quarter of patients in the Fintepla group had a ≥50% reduction in seizure frequency; 18% had a 50-75% reduction in seizure frequency; and 6% had a >75% reduction at every 28 days of treatment
.
In terms of safety, common adverse reactions in Fintepla patients (incidence of at least 10% and higher than placebo) were diarrhea, decreased appetite, fatigue, somnolence and vomiting
.
"LGS is one of the most challenging epileptic encephalopathies, and despite multiple antiepileptic drug regimens, the vast majority of patients remain poorly controlled
.
" Kelly, Children's Hospital Colorado Professor Knupp commented, "As a complementary therapy, fenfluramine offers a different mechanism of action and has been shown to significantly reduce the number of seizures associated with falls, which is one of the key measures in the management of this severe form of epilepsy.
.
"Reference: [1] US FDA Approves FINTEPLA® ▼(fenfluramine) Oral Solution for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS).
Retrieved March 28, 2022, from https:// -media/Press-Releases/article/US-FDA-Approves-FINTEPLAR-Vfenfluramine-Oral-Solution-for-Treatment-of-Seizures-Associated-with-Lennox-Gastaut-Syndrome-LGS Disclaimer: WuXi AppTec Content Team Focus on introducing the progress of global biomedical health research
.
This article is only for the purpose of information exchange.
The opinions in this article do not represent WuXi AppTec's position, nor do they support or oppose the views in the article
.
This article is not a treatment plan recommendation
.
If you need to obtain a treatment plan For guidance, please go to a regular hospital for treatment
.
