Coming five years after the Canadian regulatory approval for neuropathic pain associated with multiple sclerosis, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted GW Pharma a license to launch Sativex, a cannabis-based product, for the treatment of spasticity in patients with multiple sclerosis, which it did this week with partner German drug major Bayer (The Pharma Letter June 21).
Utilizing the European decentralized procedure with the UK acting as the reference member state, Sativex' approval signals a major landmark for the acceptance of cannabis based drugs. However, Sativex' commercial success will now hinge on future recommendations by European health advisory agencies and overcoming significant political hurdles in the USA, warns Datamonitor analyst Trung Huynh.
At $6,000 a year, will the NICE find it cost effective?
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