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Genentech warns doctors of Lucentis stroke risk
2007-01-28
Genentech Inc. has sent a letter alerting eye doctors to the risk of stroke from Lucentis, its drug for treating age-related macular degeneration, a spokeswoman said on Friday. The letter was a "proactive effort" to advise doctors that an interim analysis of a 5,000-patient trial shows that 1.2 percent of patients given a 0.5-milligram dose of the drug suffered a stroke, compared with 0.3 percent of patients given a lower 0.3-mg dose, spokeswoman Dawn Kalmar said. She said the findings are consistent with data from previous trials as well as the label for Lucentis, which was approved by the U.S. Food and Drug Administration last June. "We've have shared this information with the FDA and there is no indication, based on our discussions with the agency, that this will change the label," Kalmar said. She said early results from the ongoing trial also show that patients who had a previous stroke appear to be at greater risk of another stroke. Since its launch in June, Lucentis has come to dominate the market for treatment of the leading cause of blindness in the elderly, posting sales last year of $380 million. The drug, given by monthly injection into the eye, has an annual cost of $9,750 to $13,650. Lucentis, like Genentech's cancer drug Avastin, is designed to work by cutting off nutrients needed for growth of blood vessels. Some doctors have been using Avastin, which has a lower price tag, to treat eye patients.
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