A pharmaceutical formulation of purified cannabidiol, a cannabinoid without euphoric side effects, is expected to launch in the second half of this year.
A pharmaceutical formulation of purified cannabidiol (CBD), a cannabinoid without euphoric side effects, is expected to launch in the second half of this year.
The New Drug Application for Epidiolex (GW Pharmaceuticals) was accepted in December by FDA for 2 rare forms of epilepsy, and the agency assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 27 for Epidiolex. “If approved, the medicine is expected to be available in the US by prescription in the second half of 2018,” GW Pharmaceuticals said in a statement.
Related: FDA issues warning over marijuana products claiming cancer cure
Additionally, Epidiolex showed a reduced monthly drop in seizure frequency compared to placebo in highly treatment-resistant patients with Lennox-Gastaut syndrome (LGS), a rare, lifelong form of epilepsy, according to a new study published in The Lancet.
Over a 14-week treatment period, 44% of patients taking Epidiolex saw a significant reduction in seizures, compared with 22% of the placebo group.
Related: FDA takes tough stance on kids’ opioid cold meds
“Publication of this landmark study by The Lancet is an exciting achievement and marks the second time that Epidiolex data have been published in a highly prestigious journal, following last year’s publication in The New England Journal of Medicine,” said Justin Gover, CEO of GW Pharmaceuticals, in the statement. “These publications highlight the potential of Epidiolex to address the significant unmet need in LGS and Dravet syndrome, two very challenging epilepsy conditions, and we look forward to working with the FDA and EMA as they review our marketing applications for Epidiolex.”
“We are absolutely focused on the goal of making this important new medicine available to appropriate patients and their caregivers as quickly as possible,” Gover added.
Read next: FDA warns about contaminated drugs, dietary supplements
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More