Pfizer's neuropathic pain and epilepsy drug Lyrica has received a green light from European regulators for generalized anxiety disorder, an indication which, affecting nearly 12 million a year in Europe alone, could sharply boost the number of patients eligible for treatment with the drug.
The approval follows a positive opinion from Europe's Committee for Medicinal Products for Human Use, which gave its backing to the new indication for Lyrica (pregabalin) on January 27.
"Now that Lyrica is available, we have a new treatment option to help alleviate a broad range of emotional and physical symptoms of this prevalent condition," remarked Dr Stuart Montgomery, Professor of Psychiatry at Imperial College School of Medicine, University of London.
Although GAD is a well-recognised condition, which is characterised by excessive worrying and physical symptoms such as sleep disturbances, it remains largely under-treated.
"It is estimated that only one-third of those who suffer from this condition seek treatment despite the significant impact on patient quality of life," commented Joseph Feczko, Pfizer's chief medical officer. And the economic costs associated with the condition are also significant, with the related bill in Europe currently at around $1.5 billion, according to the company.
But the European nod is in direct contrast to the US Food and Drug Administration’s decision to reject the agent for GAD in 2004. The company has, however, not given up hope that Lyrica will also gain clearance for this indication in the USA at some point in the future, and has reportedly kept the lines of communication with the agency open over this matter, according to media reports.
Lyrica has been approved in the USA, as well as several in other countries around the globe, for treating epileptic seizures and neuropathic pain. Since its launch in the USA in September 2005, more than 500,000 prescriptions have been written for Lyrica, according to Pfizer, which said this rate made it one of its most successful product introductions.
It had already gained more than a 7% new-prescription share of the US anti-epileptic market at the end of last year, and fourth-quarter sales came in at $153 million.