Fibromyalgia - Regulatory caution threatens EU market expansion

Until regulatory hurdles in the EU are overcome, the US offers the greatest commercial potential and will be the primary growth market for all current and future brands indicated for fibromyalgia. Datamonitor forecasts the fibromyalgia market to more than double in value from 2008 to total $2.5 billion by 2018 across the seven major regions.

The probability of non-approval for fibromyalgia in the EU appears to be higher than in the US. Since 2008, the EMEA has declined marketing applications for both Cymbalta (duloxetine, Eli Lilly/Boehringer Ingelheim) and Lyrica (pregabalin, Pfizer).

Savella (milnacipran, Pierre Fabre, Cypress and Forest) became the third FDA-approved product for fibromyalgia. With a response from the EMEA anticipated shortly, Datamonitor believes the unique development program involving a composite analysis endpoint and specific EU-based Phase III study will be viewed favorably by the regulatory body.

Datamonitor has marginally downgraded its sales forecast for Xyrem (sodium oxybate, Jazz Pharma and UCB). This stems from a newly-highlighted concern over the robustness of the Phase III development program design and the negative perception surrounding the drug's formulation, its prescription constraints and abuse potential.

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• Fibromyalgia Market (24/05/2010)
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