nach einer Entscheidung der FDA sicher.
FDA panel OKs Viagra rival Bayer, GlaxoSmithKline aim for final approval soon
By Jon Groat & Ted Griffith
Last Update: 5:26 PM ET May 29, 2003
SILVER SPRING, Md. (CBS.MW) -- A new impotence remedy cleared a significant regulatory hurdle Thursday, opening the way for the drug to take on Viagra in the United States later this year.
A Food and Drug Administration advisory panel found that the drug, called Levitra, from GlaxoSmithKline (GSK: news, chart, profile) and Bayer (BAY: news, chart, profile), isn't associated with a potentially serious cardiac side effect.
The panel's finding appears to put Levitra on course to win final FDA approval. The agency typically follows the advice of its panels, which are made up of medical experts.
The panel had been called to consider whether Levitra increases the risk of a heart side effect, known as QT prolongation. If a significant risk had been established, it would have been a setback for German-based Bayer and U.K.-based GlaxoSmithKline.In after-hours action, Bayer shares jumped $1.87 to $22. GlaxoSmithKline shares were unchanged at $40.79.
A Bayer spokeswoman, Lara Crissey, has said the company hopes to win U.S. approval before the end of the year. She declined to say how much revenue Bayer and GlaxoSmithKline hope Levitra will generate.
European regulators approved Levitra in March.
Impotence treatment is a substantial market, with Viagra generating about $1.7 billion in revenue last year for maker Pfizer (PFE: news, chart, profile), the world's largest pharmaceutical company.
But challenging Viagra's dominance won't be easy. Aggressive advertising and marketing campaigns have made Viagra perhaps the best-known prescription drug in the United States.
Eli Lilly (LLY: news, chart, profile) and biotech partner Icos (ICOS: news, chart, profile) have also developed a new
anti-impotence drug. The two companies hope to win approval for that drug, called Cialis, in the second half of this year.