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Details:
FINTEPLA (fenfluramine) is a serotonin releasing agent, and thereby stimulates multiple 5-HT receptor sub-types through the release of serotonin. Fenfluramine may reduce seizures by acting as an agonist at specific serotonin receptors in the brain.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
Approval supported by clinical trial data that showed when added to existing treatment regimens, Fintepla (fenfluramine) significantly reduced monthly convulsive seizure frequency compared to placebo.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2022
Details:
Primary endpoint was met demonstrating that Fintepla (fenfluramine), as adjunctive treatment, is effective in significantly reducing the frequency of drop seizures in LGS patients compared to placebo.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
FINTEPLA® (fenfluramine) oral solution is a prescription medication approved in the U.S. and Europe, and under regulatory review in Japan, for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: UCB Pharma S.A
Deal Size: $1,900.0 million Upfront Cash: $1,900.0 million
Deal Type: Acquisition March 07, 2022
Details:
FINTEPLA (fenfluramine) is approved by the FDA and European Commission for the treatment of seizures associated with Dravet syndrome and is in development in Japan for the treatment of seizures associated with Dravet syndrome.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2022
Details:
The submission is based on the results of Phase 3, which met its primary objective in demonstrating that patients in the FINTEPLA (Fenfluramine) achieved a 64.8% greater reduction in mean monthly convulsive seizures compared to the placebo group.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2021
Details:
In the long-term trial, FINTEPLA was generally well tolerated with no observed valvular heart disease or pulmonary hypertension.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
sNDA is supported by Phase 3 Study 1601 for FINTEPLA® (fenfluramine) for treatment of seizures associated with Lennox-Gastaut Syndrome to FDA. FINTEPLA is approved by the FDA and European Commission for treatment of seizures associated with Dravet syndrome.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: PPD
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
Zogenix plans to submit a new drug application (J-NDA) for FINTEPLA in Japan for the treatment of seizures associated with Dravet syndrome by year end.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nippon Shinyaku
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2021
Details:
Across studies, FINTEPLA has been generally well-tolerated, with no observed cases of pulmonary arterial hypertension (PAH) or valvular heart disease (VHD). The most common adverse events were reported as decreased appetite, fatigue, diarrhea, and pyrexia.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
Details:
The new program supports physician access to FINTEPLA in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
Details:
More LGS study patients treated with FINTEPLA (fenfluramine) showed improvement in each of the BRIEF 2 indexes that have been used to assess behavior, emotion, and cognitive function in intractable epilepsy and other developmental conditions.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2021
Details:
Study shows that treatment with FINTEPLA not only reduces seizure activity, but also results in substantial benefits for many other aspects of the lives of those impacted by Dravet syndrome.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Fintepla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2021
Details:
Statistically significant reduction in drop seizures for FINTEPLA 0.7 mg/kg/day versus placebo. FINTEPLA also demonstrated statistically significant improvement on multiple secondary endpoints.
Lead Product(s): Fenfluramine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2020
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