Pfizer’s neuropathic pain and epilepsy drug Lyrica (pregabalin) has moved a step closer to approval in generalized anxiety disorder, an indication which could sharply increase the number of patients eligible for treatment with the drug, in the European Union.
Europe’s Committee for Medicinal Products for Human Use gave its backing to the new indication, which affects up to 5% of the entire population, on January 27. Pfizer said in a statement that GAD is a well-recognised condition - characterized by excessive worrying and physical symptoms such as sleep disturbances - but is under-treated.
Joseph Feczko, Pfizer's chief medical officer, said: "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.” The direct annual healthcare costs associated with GAD in Europe are approximately $1.5 billion, according to the company.
Lyrica was first approved for neuropathic pain and epileptic seizures in by the European Medicines Agency (EMEA) in July 2004, and for similar uses in the USA the following year.
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 as of December 23, the firm added.
Fourth-quarter sales of the product came in at $153 million.
Meanwhile, the CHMP also gave its backing late last week to:
- GlaxoSmithKline and Roche’s new three-monthly intravenous injection of the osteoporosis drug Bondenza/Bonviva (ibandronic acid). If approved by the EMEA, the formulation will be the first injectable treatment for post-menopausal osteoporosis to be made available in the EU. The drug is already available in once-daily and once-monthly oral formulations.
- Centocor and Schering-Plough’s Remicade (infliximab) as a treatment for moderately-to-severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy. Remicade is already approved in the EU for the treatment of rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis and psoriasis.
- Genzyme’s Myozyme (recombinant human acid alpha-glucosidase), as an enzyme replacement therapy in Pompe disease. If cleared, Myozyme would be the first treatment for the disease, debilitating, progressive and often fatal muscular disorder.