NICE to work with GW Pharma after Epidiolex rejection

The National Institute for Health and Care Excellence (NICE) has announced its intention to work with GW Pharma to address the issues highlighted by its independent appraisal committee, after it rejected the company’s Epidiolex (cannabidiol). The organisation did not recommend the drug in combination with clobazam for treating Dravet and Lennox-Gastaut syndromes, types of epilepsy which begin in early childhood and which are lifelong and difficult to control. The rejection occurred as the committee noted that despite the clinical trial evidence showing that the combination reduces the number of the main types of seizures associated with epilepsy, because the duration of the clinical trials was only 14 weeks, the longer-term effectiveness of the treatment is still uncertain. The committee also cited concerns about the economic models provided by the company. Importantly, they concluded that the models may not capture all aspects of severe treatment-resistant epilepsy that are important to people with these conditions, and to their carers and families. Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said that the committee was “not convinced about the way the company had modelled the effect on people living longer or having a better quality of life.”

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Business Wire | September 14, 2023

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PHARMACY MARKET

Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients

GlobeNewswire | September 12, 2023

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PHARMACY MARKET

Cytel continues expansion of market access and medical communication capabilities with the acquisition of co.faktor

Business Wire | September 28, 2023

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