Lyrica Appeal rejected

We have recently heard from Pfizer that Lyrica (Pregablin) has had its appeal rejected for being market it for the treatment of fibromyalgia in Europe. Please see the comment below:

As discussed, Pfizer is disappointed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on Pfizer’s application for an extension of indication for Lyrica® (pregabalin) to treat Fibromyalgia following the Company’s request for a re-examination of the original CHMP negative opinion.

We feel this opinion is a significant setback for people suffering with Fibromyalgia in Europe and will further exacerbate their frustrations as they wait for recognition and treatment of their condition, at a time when there are no widely available treatments in the region to fight its debilitating impact.
Pfizer sincerely appreciates the tremendous efforts undertaken by Fibromyalgia Association UK to raise the awareness of Fibromyalgia as a real condition and to obtain a more favourable environment for diagnosis and treatment of the condition.

Pfizer continues to be committed to enhancing understanding of Fibromyalgia and providing needed therapies that are effective and have a good safety profile. In doing so, we will continue to work in strong partnership with patients.

Last Updated on Tuesday, 28 July 2009 18:37 Created: Tuesday, 28 July 2009 17:32