Genentech has issued a letter to doctors warning them that Lucentis, its treatment for wet age-related macular degeneration, may be linked to an increased risk of stroke.
In the letter to physicians, Genentech, which developed the drug with Novartis, stated that interim results from the SAILOR trial showed that 1.2% of patients who received a 0.5mg dose of Lucentis (ranibizumab) suffered a stroke, compared to 0.3% of patients who received a 0.3mg dose, which is statistically significant, and the findings suggest that patients in the study who had previously suffered a stroke may be at greater risk of suffering another one.
Genenetech says that the information has been shared with the US Food and Drug Administration and the firm does not believe that the agency will change the label of Lucentis, seeing as it already gives information about a potential risk of adverse events such as strokes and heart attacks.
Lucentis, which has just received the green light in the European Union, has proved to be a spectacular success since it was launched in the USA last July. It contributed $217 million in only its second full quarter since coming onto the US market to Genentech’s coffers, a figure that easily surpassed analysts’ consensus and this latest news about stroke risk, and the small percentage involved, is not expected to damage sales severely.
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