In a letter sent to 1,500 eye doctors, Genentech is warning that its macular degeneration drug, Lucentis, may increase the risk of stroke if administered in high doses. Approved a mere six months ago by the FDA, Lucentis has already generated nearly $400 million in sales for Genentech, although the latest news may hurt the drug’s economic performance.
The company announced that preliminary findings from a 5,000-patient trial found that 1.2 percent of patients taking high doses (0.5 mg) of Lucentis suffered a stroke while only 0.3 percent of low-dose (0.3 mg) patients had a stroke. The difference in dosages does not appear to affect the incidence of heart failure.
Genentech has alerted the FDA about their latest findings and does not anticipate the agency making any labeling changes or safety warnings. The Lucentis label already has a warning about blood-clot-related risks such as strokes and heart attacks.
For most patients, the price tag for Lucentis is roughly $10,000 per year. Macular degeneration is the leading cause of blindness in elderly patients, and the drug has become wildly popular as a remedy for vision problems among that population.
