Lennox–Gastaut syndrome

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.

FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease

Saturday, August 1, 2020 - 2:06am

Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).

Key Points: 
  • Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).
  • This is the only FDA-approved drug that contains a purified drug substance derived from cannabis.
  • It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.
  • It is THC (and not CBD) that is the primary psychoactive component of cannabis.

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.

2020 Lennox Gastaut Syndrome Market - Insights, Epidemiology & Market Forecast - ResearchAndMarkets.com

Wednesday, July 29, 2020 - 11:12am

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

Key Points: 
  • The "Lennox Gastaut Syndrome - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • Lennox Gastaut Syndrome (LGS) - Market Insights, Epidemiology, and Market Forecast - 2030' report deliver an in-depth understanding of the Lennox Gastaut Syndrome (LGS), historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
  • The Report also covers current Lennox Gastaut Syndrome (LGS) symptoms treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
  • The disease epidemiology covered in the report provides historical as well as forecasted Lennox Gastaut Syndrome (LGS) epidemiology segmented as the Total Prevalent cases of Lennox Gastaut Syndrome (LGS), Diagnosed Prevalent Cases of Lennox Gastaut Syndrome (LGS), Gender-Specific cases of Lennox Gastaut Syndrome (LGS), Seizure-specific cases of Lennox Gastaut Syndrome (LGS).

Lennox Gastaut Syndrome Pipeline Insights Report, 2020 - ResearchAndMarkets.com

Thursday, July 2, 2020 - 4:41pm

This report outlays comprehensive insights of present clinical development scenario and growth prospects across the Lennox Gastaut Syndrome market.

Key Points: 
  • This report outlays comprehensive insights of present clinical development scenario and growth prospects across the Lennox Gastaut Syndrome market.
  • A detailed picture of the Lennox Gastaut Syndrome pipeline landscape is provided, which includes the disease overview and Lennox Gastaut Syndrome treatment guidelines.
  • The assessment part of the report embraces in-depth Lennox Gastaut Syndrome commercial assessment and clinical assessment of the Lennox Gastaut Syndrome pipeline products from the pre-clinical developmental phase to the marketed phase.
  • It comprises of detailed profiles of Lennox Gastaut Syndrome therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
    Detailed Lennox Gastaut Syndrome research and development progress and trial details, results wherever available, are also included in the pipeline study.

Zogenix to Participate in the BofA Securities 2020 Virtual Healthcare Conference

Wednesday, May 6, 2020 - 1:00pm

Zogenix is 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: 
  • Zogenix is 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 company has two late-stage development programs underway: FINTEPLA (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

Zogenix to Release First Quarter 2020 Financial Results and Host Conference Call and Webcast on May 5

Tuesday, April 28, 2020 - 1:00pm

Zogenix is 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: 
  • Zogenix is 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 company has two late-stage development programs underway: FINTEPLA (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

Ovid Therapeutics Announces Initial Data with Soticlestat in CDKL5 Deficiency Disorder and Dup15q Syndrome

Monday, March 30, 2020 - 1:00pm

We will work closely to evaluate the full data from the ARCADE study, expected in the first quarter of 2021.

Key Points: 
  • We will work closely to evaluate the full data from the ARCADE study, expected in the first quarter of 2021.
  • More data is needed to assess efficacy, but initial data support the potential of soticlestat to provide a clinical benefit for patientswith these ultra-rare and treatment-refractory epilepsy disorders.
  • Data from the first 11 patients suggests that soticlestat may reduce seizure frequency compared to baseline levels in individual patients.
  • The FDA has granted orphan drug designation to soticlestat for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome.

JAMA Neurology Publishes Results from Positive Phase 3 Trial of EPIDIOLEX® (cannabidiol) oral solution in Children with Seizures Associated with Dravet Syndrome

Monday, March 2, 2020 - 4:14pm

The data published by JAMA Neurology show that EPIDIOLEX 10 and 20 mg/kg/day were both efficacious and significantly reduced convulsive seizures.

Key Points: 
  • The data published by JAMA Neurology show that EPIDIOLEX 10 and 20 mg/kg/day were both efficacious and significantly reduced convulsive seizures.
  • We are pleased that the full results of our GWPCARE2 study in Dravet syndrome are now available to the greater neurology community.
  • Results from the first positive Phase 3 pivotal trial of EPIDIOLEX in patients with Dravet syndrome were published in The New England Journal of Medicine.1 The EPIDIOLEX clinical program now includes five positive randomized, controlled Phase 3 clinical trials in Lennox-Gastaut Syndrome, Dravet syndrome and tuberous sclerosis complex.
  • In the U.S., EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.