The US Food and Drug Administration has expanded approval on Roche’s eye blockbuster Lucentis.
The agency has given the green light for Lucentis (ranibizumab) to treat diabetic retinopathy in patients with diabetic macular oedema (DME). The once-monthly injection “is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol”, it added.
The approval is based on two Phase III studies involving 759 participants who were treated and followed for three years. Patients injected with Lucentis showed significant improvement in the severity of their DR at two years compared to patients who did not receive an injection.
On the basis of the trial data, the FDA granted Lucentis breakthrough therapy designation and priority review in the aforementioned indication, representing the fourth US approval for the big-selling vascular endothelial growth factor inhibitor. In 2012, Lucentis was the first med approved by the FDA for the treatment of DME. Lucentis, with subsequent green lights for wet age-related macular degeneration (2006) and macular 0edema following retinal vein occlusion (2010).
Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said the approval gives patients with DR and DME “the first significant therapy to treat this vision-impairing complication”.
This latest approval will boost the already-considerable sales of Lucentis, which is sold outside the USA by Novartis. It contributed 1.70 billion Swiss francs to Roche’s coffers in the fourth quarter of 2014.