GW Pharmaceuticals Receives Orphan Drug Designation from the European Medicines Agency (EMA) | CashCropToday
0 Shares 352 Views

GW Pharmaceuticals Receives Orphan Drug Designation from the European Medicines Agency (EMA)

February 27, 2018
352 Views

On February 27, 2018, GW Pharmaceuticals, PLC (Nasdaq:GWPH) (“GW) announced that the European Medicines Agency (EMA) has granted orphan drug designation for cannabidiol (CBD) for the treatment of tuberous sclerosis (TS).

GW has started a Phase 3 clinical trial of Epidiolex® (cannabidiol) as an adjunctive therapy for the treatment of seizures associated with TS, with data expected in the second half of 2018.  Subject to positive results, GW will submit regulatory applications in 2019 for Epidiolex in TS in both the U.S. and Europe.

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas.

The EMA orphan designation is a status assigned to a medicine intended for use against a rare, chronically debilitating, condition and allows a pharmaceutical company to benefit from incentives offered by the EU.  These incentives can include reduced fees and protection from competition once the medicine is placed on the market. At the time of designation, tuberous sclerosis affected approximately 52,000 people in the European Union.

Tuberous sclerosis, also called tuberous sclerosis complex (TSC), is a rare, multi-system genetic disease that causes benign tumors to grow in the brain and on other vital organs such as the kidneys, heart, eyes, lungs, and skin. It usually affects the central nervous system and results in a combination of symptoms including seizures, developmental delay, behavioral problems, skin abnormalities, and kidney disease.

You may be interested

OTC Markets Group Welcomes TerrAscend Corp. to OTCQX
Market Watch
9 views
Market Watch
9 views

OTC Markets Group Welcomes TerrAscend Corp. to OTCQX

Jaelynn Offerman - October 22, 2018

OTC Markets Group Inc. (OTCQX: OTCM), operator of financial markets for 10,000 U.S. and global securities, today announced TerrAscend Corp. (CSE: TER; OTCQX: TRSSF), a biopharmaceutical and wellness company that…

Pivot Pharmaceuticals Signs Agreement with Licorera Del Sur Subsidiary Cartagena Inc. To Create Joint Venture To Commercialize Cannabis-Infused Non-Alcoholic Beverages
Global
7 views
Global
7 views

Pivot Pharmaceuticals Signs Agreement with Licorera Del Sur Subsidiary Cartagena Inc. To Create Joint Venture To Commercialize Cannabis-Infused Non-Alcoholic Beverages

Jaelynn Offerman - October 22, 2018

Pivot Pharmaceuticals, Inc. (CSE: PVOT / OTCQB: PVOTF / FRA: NPAT) ("Pivot" or the "Company") is pleased to announce that it has signed a Letter of Intent to create a Joint Venture…

MedMen to Sell Three Retail Locations to Treehouse Real Estate for $12.5M
Market Watch
42 views
Market Watch
42 views

MedMen to Sell Three Retail Locations to Treehouse Real Estate for $12.5M

Editor - October 19, 2018

MedMen Enterprises Inc. (CSE: MMEN) (OTCQB: MMNFF) announced this week that the company has agreed to sell three seperate cannabis retail locations to Treehouse Real Estate Investment…

Leave a Comment

Your email address will not be published.

Most from this category

%d bloggers like this: