Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2022
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 27, 2022
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 02, 2022
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : UCB Pharma S.A
Deal Size : $1,900.0 million
Deal Type : Acquisition
UCB Completes Acquisition of Zogenix, Inc.
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.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : $1,900.0 million
March 07, 2022
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : UCB Pharma S.A
Deal Size : $1,900.0 million
Deal Type : Acquisition
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 04, 2022
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 21, 2021
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : In the long-term trial, FINTEPLA was generally well tolerated with no observed valvular heart disease or pulmonary hypertension.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2021
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : PPD
Deal Size : Not Applicable
Deal Type : Not Applicable
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 syndr...
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 28, 2021
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : PPD
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Nippon Shinyaku
Deal Size : Not Applicable
Deal Type : Not Applicable
Zogenix Receives Orphan Drug Designation for FINTEPLA® (Fenfluramine) in Japan
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.
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 26, 2021
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Nippon Shinyaku
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 pyrexi...
Brand Name : Fintepla
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 21, 2021
Lead Product(s) : Fenfluramine
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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