GW Pharmaceuticals PLC GWPH Stock NewsUPDATE – GWPH receives FDA approval for Epidolex, marking a milestone in the use of CBD in the medical setting!

Don't Miss The Next FDA Approval

Subscribe to PDUFA Watch from iWatch Markets and you'll receive alerts a week before the PDUFA date. We'll tell you if the drug is likely to be approved and when to be watching!

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) is next up on PDUFA Watch, and it’s likely to be a good one! The company’s PDUFA date is June 27th, a day that many are betting the company will receive approval for a completely new class of medicine. Here’s the deal:

GWPH Is Likely To Receive Approval

While there is no telling what might happen until the FDA gives their final response, things are looking incredibly positive for GW Pharmaceuticals and its New Drug Application surrounding a medication known as Epidolex.

Epidolex is a treatment created by GWPH that is in a whole new class of medications. The active ingredient in the treatment, purified cannabidiol, is derived from the marijuana plant. The treatment was made famous with a strain of marijuana known as Charlotte’s Webb that was developed for the treatment of a young girl that suffered from seizures due to a severe form of epillepsy. With the use of oil from the strain, Charlotte, the child suffering from the seizures saw an incredible reduction in the amount of seizures experienced.

Since then, various biotechnology companies have been working to use marijuana to treat epillepsy, and GWPH is just days away from having an approved option to market. Epidolex was developed by GW Pharmaceuticals and has performed overwhelmingly well in clinical trials.

In the most recent study of 171 patients suffering from Lennox-Gastaut syndrome (a severe form of epillepsy), data was overwhelmingly promising. Most of the patients int he study have tried and had poor results from six different anti-seizure medications. Also, most of the patients were experiencing at least 74 “drop: seizures per month. These types of seizures are overwhelmingly dangerous as they generally result in an injury or fall.

The results of the study were hard to ignore. Over a 14 week period, 44% of patients saw a substantial decline in seizures while 22% of the placebo arm saw results. Importantly, patients in the Epidolex arm experienced a 50% or more decline in drop seizures!

The Market Opportunity Is Incredible

The epillepsy market is a massive one. In fact, it is estimated that in the United States, one in 26 people are diagnosed with the condition. That is a massive market. However, the opportunity isn’t a strong opportunity simply because of market size. The truth of the matter is that upon approval, should it take place, GWPH will have a competitive advantage.

Don't Miss The Next FDA Approval

Subscribe to PDUFA Watch from iWatch Markets and you'll receive alerts a week before the PDUFA date. We'll tell you if the drug is likely to be approved and when to be watching!

In the clinical trials, Epidolex not only proved to be overwhelmingly effective in treating this severe form of epillepsy, the safety profile was second to none. At the end of the day, should the treatment be approved by the FDA, it will be one of the safest, if not the safest medication used to treat this condition. Coupled with strong efficacy, this could quickly grab the market by the horns!

Be Ready For The Opportunity 

As mentioned above, the PDUFA date for Epidolex is June 27th, just a week away! With the strong data, the FDA’s Advisory Committee unanimously voted to approve the treatment, it’s hard to imagine that it would be rejected for any reason. This, combined with the strong market opportunity represents suggests that when approval does come down the line, the stock could fly!

Don't Miss The Next FDA Approval

Subscribe to PDUFA Watch from iWatch Markets and you'll receive alerts a week before the PDUFA date. We'll tell you if the drug is likely to be approved and when to be watching!

LEAVE A REPLY

Please enter your comment!
Please enter your name here