Pfizer gets EU OK, it first, for Lyrica in neuropathic pain and add-on epilepsy

World pharmaceutical industry leader Pfizer has received its firstapproval, from the European Commission, to market Lyrica (pregabalin) in all 25 European Union member states for the treatment of peripheral neuropathic pain and as an adjunctive therapy for partial seizures in patients with epilepsy. Developed by Pfizer, Lyrica is a new compound with analgesic and anticonvulsant properties.

The drug was recommended for approval by the EU's Committee for Proprietary Medicinal Products earlier this year (Marketletter April 5) and is pending clearance by the US Food and Drug Administration, which has called on Pfizer to present additional toxicology data as Lyrica produced tumors in mice in preclinical trials. In the USA, it is under FDA review for the management of neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster, as adjunctive therapy for partial seizures and the treatment of generalized anxiety disorders in adults. The company is also seeking the latter indication in the EU, which has yet to be granted.

$2.25 billion a year sales potential and will replace patent-expiring Neurontin