Roche’s Lucentis Receives Fourth US Regulatory Approval
Roche has today announced that the US Food and Drug Administration (FDA) has expanded regulatory approval on their eye blockbuster, Lucentis.
The regulatory agency granted approval for Lucentis (ranibizumab) to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
The FDA noted that the once-monthly injection “is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol.”
Nearly 29 million Americans have diabetes. The longer a person has diabetes, the higher the risk of them developing diabetic retinopathy, especially if their diabetes is poorly managed. DME currently impacts nearly 750,000 Americans, and can occur at any stage of diabetic retinopathy.
The approval was based on two Phase III clinical studies, which involved 759 participants who were treated and monitored for three years. Patients injected with Lucentis showed significant improvement in the severity of their DR after two years in comparison to patients who did not receive an injection.
Based on the clinical trial data, the FDA granted Lucentis breakthrough therapy designation and priority review, representing the fourth US regulatory approval for Lucentis.
Sandra Horning, M.D., chief medical officer and head of Global Product Development at Roche, noted that “while there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy,” adding that “people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision.”
In 2012, Lucentis was the first treatment approved by the US FDA for the treatment of DME. The treatment also previously received approvals for wet age-related macular degeneration (2006) and macular edema following retinal vein occlusion (2010).