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GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) is inching closer to clearing another regulatory hurdle with respect to its cannabidiol drug Epidiolex, potentially opening up a market opportunity in Europe.
The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, issued a positive opinion on Epidiolex, the company said Friday.
The panel is recommending approval of Epidiolex for use as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome, or LGS — or Dravet syndrome in combination with clobazam — in patients two years and older.
Epidiolex is an oral solution containing highly purified cannabidiol with a novel mechanism of action. It has an Orphan Drug Designation from the EMA for treating seizures associated with LGS, Dravet syndrome and tuberculosis sclerosis complex.
The drug received FDA approval in June 2018 and launched commercially in the U.S. in November 2018
The product fetched GW Pharma sales of $33.5 million in the first quarter of 2019.
The company submitted the marketing authorization application to the EMA in December 2017, with the agency accepting it for review in February 2018.
"We are excited by the potential to bring patients and physicians a rigorously tested and evaluated cannabis-based medicine with a documented safety and efficacy profile, manufactured to the highest standards and approved by a medicines regulator," CEO Justin Grover said in a statement.
The CHMP opinion is positive for GWPH, Cantor Fitzgerald's Elemer Piros said in a Friday note.
The label inclusion of clobazam is unlikely to deter prescriptions in the EU, given the high unmet medical need and numerous positive Phase 3 data reported from GWPH, the analyst said.
"On the pricing front, GWPH does not believe pricing will be impacted, and remains confident on obtaining reimbursement in key markets."
Cantor Fitzgerald has an Overweight rating on GW Pharma with a $229 price target.
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The European Commission is expected to a make a final decision on the regulatory application in about two months.
The approval, if it comes through, will authorize the company to market the drug in 28 EU nations, alongside Norway, Inceland and Liechtenstein.
GW Pharma shares were trading higher by 2.2% at $164.64 at the time of publication Friday.
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Photo courtesy of GW Pharma.
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