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epilepsy

China approves Eisai's Fycompa for partial onset epileptic seizures

Tokyo-headquartered firm Eisai has announced that its antiepileptic drug (AED) Fycompa (perampanel) has received approval from China’s National Medical Products Administration (NMPA) for the adjunctive treatment of partial onset epileptic seizures(with or without secondarily generalised seizures) in patients over the age of 12.

The decision, awarded under the Administration’s Priority Review pathway in just over 12 months, was based on data from a number of Phase 3 studies which indicated that Fycompa reduced seizure frequency by 17.3%, 29% and 38.9% in its 4, 8 and 12mg formulatio

GW Pharma's cannabis-based Epidyolex edges closer to EU approval with positive CHMP opinion in epilepsy

UK-based biotech GW Pharmaceuticals has announced that its cannabidiol oral solution Epidyolex has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The specialist panel chose to endorse the therapy and push for its approval, in combination with clobazam, as an adjunctive treatment for seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome in patients at least two years old.

Pfizer's Lyrica fails at Phase 3 in treating primary generalised tonic-clonic (PGTC) seizures

Pfizer has unveiled new Phase 3 data on the effectiveness of Lyrica (pregabalin) in the adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients between the ages of five and 65 years old, revealing that the therapy failed to meet its primary endpoint.

Specifically, Pfizer announced that use of the drug did not lead to a statistically significant reduction in seizure frequency compared to placebo in testing of 219 participants. However, the manufacturer did note that the drug’s safety profile was consistent with previous findings.

GW Pharma's Epidiolex scores in rare childhood onset epilepsy Phase 3 trial

GW Pharma’s Epidiolex has shown positive Phase 3 trial results for the fifth time in a row, after meeting primary endpoints in a randomised, double blind, clinical study of patients with Tuberous Sclerosis Complex (TSC), a rare form of childhood onset epilepsy.

The CBD-based drug reduced seizures by 48.6% and 47.5% from baseline at doses of 25 and 50 mg/kg/day in patients with TSC, compared to a rate of 26.5% for placebo.

Epilepsy Society calls for review of UK supply chain following "steep rise" in access issues

The Epilepsy Society has drawn attention to the “steep rise” in UK patients who are encountering difficulty in accessing seizure medication.

While issues around access to these medicines have been or could be further exacerbated by Brexit, the society asserts that this has been a problem for over a decade, and one which Big Pharma has continuously failed to address.

The society has said that its “Helpline and enquiries desk inundated with worried callers”, and the added anxiety and stress is compounding the risk of seizures in patients.

Antiepileptics increase the risk of pneumonia in people with Alzheimer’s disease

Image Credit: GerryShaw

Antiepileptic drugs increase the risk of pneumonia in people living with Alzheimer’s disease, according to research from the University of Eastern Finland.

People with Alzheimer’s who used antiepileptics have twice the risk of developing pneumonia compared to those not using the drugs, the study, published in the Journal of Alzheimer’s Disease says.

UCB teams up with charity to beat treatment-resistant epilepsy in $2.5m partnership

Belgian firm UCB Pharma has announced a new partnership with the charity Epilepsy Society which will see the pair invest $2.5 million over the next five years as part of a project to develop greater understanding of the pathology of epilepsy and how to effectively treat treatment-resistant patients with the condition.

Both partners chose to launch the collaboration on 11 February to mark International Epilepsy Day.

Pfizer's Lyrica achieves endpoint as adjunct in paediatric epilepsy

Pfizer has revealed new Phase 3 data for its oral epilepsy therapy Lyrica (pregbalin) as an adjunctive treatment for partial onset seizures associated with the condition in paediatric patients aged from one month to less than four years, demonstrating that higher dose of the drug met its primary endpoint in the study.  

MHRA bans sodium valproate in the UK following birth defect controversy

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that sodium valproate, a drug used in the treatment of epilepsy and bipolar disorder which is sold by Sanofi under the brand Depakine and Depakote/Depamide respectively, has been banned in the UK as aconsequence of its links to birth defects in children. It will now only be available under a special pregnancy prevention programme.

Antiepileptic drug use linked to increased risk of Alzheimer's and dementia

A new study conducted at the University of Eastern Finland and the German Center for Neurodegenerative Diseases (DZNE) has revealed a link between antiepileptic drug use and an increased risk of developing Alzheimer’s disease and dementia.

The study derived data from the nationwide register of all 70,718 citizens in Finland diagnosed with Alzheimer’s disease between 2005 and 2011, as well as a 20,325-strong sample from German statutory health insurance provider Allgemeine Ortskrankenkasse of patients diagnosed with dementia between 2004 and 2011.

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