GEN Exclusives

More »

GEN News Highlights

More »
Jul 28, 2010

Spain Approves Cannabis-Derived MS Therapy as GW Pharm Files for New EU Approvals

  • GW Pharmaceuticals confirmed Spanish regulatory authority clearance for Sativex® as an add-on therapy for treating moderate-to-severe spasticity in multiple sclerosis patients who don’t respond adequately to other antispasticity drugs. Approval of the cannabinoid oromucosal spray in Spain follows on from approval of the drug in the U.K. in June.

    GW’s marketing partner for Sativex in Europe (excluding the U.K.) is Almirall. The firms point out launch of Sativex in Spain will have to wait until pricing and reimbursement approval has been agreed to by the country’s ministry of health. They expect this final approval process to be completed during the fourth quarter of 2010.

    GW Pharmaceuticals says it has also submitted an application for approval of Sativex in other EU countries via the European Mutual Recognition Procedure (MRP). The U.K. will act as the reference member state for the process. A full list of countries to which the MRP application relates has yet to be finalized.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Alzheimer's Therapies

Do you think an effective treatment for Alzheimer’s will be found within the next 10–15 years?