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.
