Dravet syndrome

Global Dravet Syndrome Industry Assessment 2017-2030: Epidemiology, Pipeline, Drugs, Competitive Intelligence Analysis

Thursday, August 6, 2020 - 11:45am

The Dravet Syndrome epidemiology chapters provide insights about historical and current Dravet Syndrome patient pool and forecasted trend for every seven major countries.

Key Points: 
  • The Dravet Syndrome epidemiology chapters provide insights about historical and current Dravet Syndrome patient pool and forecasted trend for every seven major countries.
  • Incidence of Dravet Syndrome segments Dravet Syndrome epidemiology, Mutation positive cases, Mutation Cases by Types and Class, Seizures associated with Dravet Syndrome, Gender-specific cases and Age-specific cases of Dravet Syndrome.
  • Drug chapter segment of the Dravet Syndrome report encloses the detailed analysis of Dravet Syndrome pipeline drug.
  • The publisher performs Competitive and Market Intelligence analysis of the Dravet Syndrome Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc.

Zogenix Provides Corporate Update and Reports Second Quarter 2020 Financial Results

Wednesday, August 5, 2020 - 9:01pm

This was a significant milestone for Zogenix and those in the Dravet community seeking effective new treatment options.

Key Points: 
  • This was a significant milestone for Zogenix and those in the Dravet community seeking effective new treatment options.
  • Last week, we commenced the commercial launch of FINTEPLA in the United States and are very pleased with our early progress.
  • Research and development expenses for the second quarter endedJune 30, 2020, totaled$34.4 million, up from$27.1 millionin the second quarter endedJune 30, 2019, as the Company decreased spending in Dravet syndrome and expanded clinical activities in LGS and MT1621.
  • As ofJune 30, 2020, the Company had$390.2 millionin cash, cash equivalents, and marketable securities, compared to$251.2 millionatDecember 31, 2019.

Dravet Syndrome Market Insights, Epidemiology and Forecasts to 2030 - ResearchAndMarkets.com

Tuesday, August 4, 2020 - 2:34pm

The "Dravet Syndrome Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Dravet Syndrome Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The Dravet Syndrome epidemiology chapters provide insights about historical and current Dravet Syndrome patient pool and forecasted trend for every seven major countries.
  • Incidence of Dravet Syndrome segments Dravet Syndrome epidemiology, Mutation positive cases, Mutation Cases by Types and Class, Seizures associated with Dravet Syndrome, Gender-specific cases and Age-specific cases of Dravet Syndrome.
  • Drug chapter segment of the Dravet Syndrome report encloses the detailed analysis of Dravet Syndrome pipeline drug.

FDA Approves EPIDIOLEX® (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex

Monday, August 3, 2020 - 12:00pm

FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex, said Justin Gover, GWs Chief Executive Officer.

Key Points: 
  • FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex, said Justin Gover, GWs Chief Executive Officer.
  • FDA approval of EPIDIOLEX in TSC is a tremendous step forward and our community applauds this positive development, said Kari Luther Rosbeck, President and CEO of the Tuberous Sclerosis Alliance.
  • In the U.S., EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in patients one year of age and older.
  • EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

Tuberous Sclerosis Alliance Lauds FDA Approval of Epidiolex® to Treat Seizures in People with Tuberous Sclerosis Complex

Saturday, August 1, 2020 - 2:43am

SILVER SPRING, Md., July 31, 2020 /PRNewswire/ --Today, the Tuberous Sclerosis Alliance (TS Alliance) lauds the U.S. Food and Drug Administration's (FDA's) approval of Epidiolex oral solution to treat seizures in people one year of age and older who have tuberous sclerosis complex (TSC).

Key Points: 
  • SILVER SPRING, Md., July 31, 2020 /PRNewswire/ --Today, the Tuberous Sclerosis Alliance (TS Alliance) lauds the U.S. Food and Drug Administration's (FDA's) approval of Epidiolex oral solution to treat seizures in people one year of age and older who have tuberous sclerosis complex (TSC).
  • "Up to 85 percent of those affected by TSC experience seizures at some point in their lifetime," explained TS Alliance President & CEO Kari Luther Rosbeck.
  • In 2018, the FDA approved the drug to treat people two years of age and older with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.
  • Established in 1974, the Tuberous Sclerosis Alliance is an internationally recognized nonprofit organization dedicated to finding a cure for tuberous sclerosis complex while improving the lives of those affected.

Zogenix to Release Second Quarter 2020 Financial Results and Host Conference Call and Webcast on August 5

Wednesday, July 29, 2020 - 1:00pm

Zogenixis a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.

Key Points: 
  • Zogenixis a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.
  • The companys first rare disease therapy, FINTEPLA(fenfluramine) oral solution, C-IV has been approved by theU.S.FDA and is under review inEuropefor the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy.
  • In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and one for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.
  • MT1621 is being developed through Modis Therapeutics, aZogenixcompany.

FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome

Friday, June 26, 2020 - 4:05am

About FINTEPLA (fenfluramine) oral solution, CIV

Key Points: 
  • About FINTEPLA (fenfluramine) oral solution, CIV
    FINTEPLA is an approved treatment, in the U.S., for seizures associated with Dravet syndrome in patients 2 years of age and older.
  • Across multiple clinical studies, FINTEPLA demonstrated significant and sustained reduction of convulsive seizures associated with Dravet syndrome.
  • If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.
  • The company's first rare disease therapy, FINTEPLA (fenfluramine) oral solution, C-IV has been approved by the U.S. FDA and is under review in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy.

FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome

Friday, June 26, 2020 - 1:49am

Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.

Key Points: 
  • Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.
  • About FINTEPLA (fenfluramine) oral solution, CIV
    FINTEPLA is an approved treatment, in the U.S., for seizures associated with Dravet syndrome in patients 2 years of age and older.
  • Across multiple clinical studies, FINTEPLA demonstrated significant and sustained reduction of convulsive seizures associated with Dravet syndrome.
  • If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

FDA Approves New Therapy for Dravet Syndrome

Friday, June 26, 2020 - 12:50am

Dravet syndrome is a life-threatening, rare and chronic form of epilepsy.

Key Points: 
  • Dravet syndrome is a life-threatening, rare and chronic form of epilepsy.
  • "Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome.
  • The FDA will continue to work with companies on drug development for Dravet syndrome and other types of epilepsy."
  • The effectiveness of Fintepla for the treatment of seizures associated with Dravet syndrome was demonstrated in two clinical studies in 202subjects between ages 2 and 18.

Zogenix Introduces New Resources for Dravet Syndrome Siblings

Friday, June 12, 2020 - 1:00pm

Dravet syndrome is a rare, severe childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.

Key Points: 
  • Dravet syndrome is a rare, severe childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.
  • The severity and unpredictability of Dravet syndrome, coupled with around-the-clock concern for the family member with Dravet syndrome, can cause significant challenges for all members of the family and increase a siblings risk for anxiety and depression.
  • The VIP Sibling Kits for children ages 4-18 contain:
    The materials were presented to the U.S.-based Dravet syndrome community this week in a special Dravet Syndrome Foundation webinar and will be available through the Dravet Syndrome Foundation starting August 1, 2020.
  • Zogenix has worked with the Dravet Syndrome Foundation, the broader Dravet community, and a variety of other Dravet syndrome and mental health experts to better understand and address the impact of rare epilepsies on caregivers, families, and siblings.