Pfizer's latest candidate for blockbuster status, central nervous system drug pregabalin has been given a positive opinion by the EU Committee for Proprietary Medicinal Products (CPMP), paving the way for a launch in the second half of 2004.

The drug, which is to gain licenses for the treatment of neuropathic pain and as an adjunctive treatment for partial seizures has been given the brand name of Lyrica, and looks set to hit European markets before its US launch.

The FDA is currently reviewing Lyrica for a remarkable four separate indications at once: neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster (post herpetic neuralgia), as adjunctive therapy in the treatment of seizures and for the treatment of generalised anxiety disorder in adults.

The drug is a follow-up to the company's older CNS drug Neurontin which achieved peak sales of $2.7 billion in 2003, a figure analysts expect Lyrica to eventually match. Off-label prescribing of Neurontin has played a great part in its success, and the new drug's broad range of applications means it will enjoy similar unlicensed use by doctors.

Meanwhile, another major Pfizer product, heart failure treatment Inspra (eplerenone) has gained its first European approval in the Netherlands.

The drug will be used to treat heart failure in patients who have recently suffered a heart attack, and works by inhibiting the effects of aldosterone, a hormone linked to the development and progression of hypertension and heart failure.

Heart failure is a growing problem, affecting an estimated 10 million Europeans, with a 50% mortality rate within five years.

In the UK, the annual cost of heart failure to the NHS is estimated to be £1.3 billion. NHS heart czar Roger Boyle has called heart failure a 'Cinderella disease' and is now focusing on increasing its identification and treatment.

Pfizer says it anticipates launching Inspra in the Netherlands later this year, with other European markets to follow.

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Pfizer submits blockbuster follow up to Neurontin

Wednesday, November 12, 2003

pharmafocus@pharmafile.co.uk