First marijuana-derived drug poised for FDA approval
First marijuana-derived drug poised for FDA approval
CBD Medication Gets Initial Acceptance From U.S. Health Officials
20 April, 2018, 01:50
If the Food and Drug Administration follows the group's recommendation, GW Pharmaceuticals' syrup would become the first drug derived from the cannabis plant to win federal approval in the U.S.
"Furthermore, the acknowledgement by the FDA of cannabis' potential medical efficacy is likely to rekindle debates as to the proper classification of cannabis, and particularly cannabidiol (CBD), the main active ingredient in GW's product, under the Controlled Substances Act". With less than 0.1% THC, the drug does not have a psychoactive component.
A synthetic form of THC, FDA-approved Marinol, has been on the market for years as an appetite stimulant or antiemetic (to prevent vomiting or nausea). Approval would technically limit the drug, called Epidiolex, to patients with hard-to-treat forms of epilepsy.
The unanimous support of the 13-member FDA advisory committee seemed assured after agency staff members gave the drug a positive review, saying that clinical trials showed that it was effective at reducing seizures and that side effects, including possible liver complications, could be managed.
"This is clearly a breakthrough drug for an terrible disease", said Dr. John Mendelson, a panel member and senior research scientist at Friends Research Institute.
Polly Vanderwoude said her daughter, Olivia, began having seizures in 2010 when she was 2 months old, and had multiple seizures a day.
- A medicine made from the marijuana plant moved one step closer to US approval Thursday after federal health advisers endorsed it for the treatment of severe seizures in children with epilepsy. "If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis". Sam Vogelstein, 16, said he experienced daily seizures - at times more than 100 per day- before enrolling in a study of the drug.
Epidiolex is essentially a pharmaceutical-grade version of cannabidiol, or CBD oil, which some parents have used for years to treat children with epilepsy.
Since marijuana is restricted as a Schedule 1 drug by the DEA, FDA staff said during the advisory meeting that cannabidiol will need to be rescheduled to be made available for sale if approved.
Shares of GW Pharmaceuticals did not surge much on the news, as the market had already anticipated a decision and traded on speculation, with the stock gaining more than 5.6 percent since Monday.
As per Wednesday, April 11, the company rating was maintained by Keefe Bruyette & Woods. ( NYSE :CMI) rating on Monday, July 10. Renaissance Technologies LLC raised its position in shares of Philip Morris International by 93.5% during the 4th quarter.
The additional Rs 1,000 crore after the initial infusion of Rs 500 crore will come at a valuation of Rs 161.60 per share. It is hereby informed that the company today (on Thursday) has received a supplemental proposal from IHH.
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On April, 24 Eli Lilly and Company (LLY) Analysts See $1.13 EPS
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