The authorities in Italy have granted commercialization approval for GW Pharmaceuticals' Sativex prescription medication.
Sativex is indicated for the treatment of moderate to severe spasticity in multiple sclerosis (MS) in patients who showed inadequate response to other anti-spasticity medications.
GW chief executive officer Justin Gover said along with Italy, the total to 21 countries approved Sativex as the treatment of MS spasticity.
"In granting reimbursement approval for Sativex, we appreciate the foresight of the Italian authorities in recognizing the value of a medicine that treats a particularly debilitating symptom of MS that is not adequately treated with currently available medications," Gover added.
The publication of Sativex in the Italian Official Journal (Gazzetta Ufficiale) reflects that regulatory, pricing and reimbursement approvals are completed and the commercial launch by Almirall, GW's partner, is expected in September 2013.
The publication of Sativex in Gazzetta Ufficiale resulted in a €250,000 milestone payment to GW from Almirall.
