FDA grants Priority Review for Lucentis in diabetic retinopathy

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted to file the company’s supplemental Biologics License Application (sBLA) and granted Priority Review of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA confirmed action date is February 6, 2015.

The sBLA was submitted August 7, 2014 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients.

“Diabetes has emerged as a global epidemic, with 29 million people in the U.S. with diabetes at risk of diabetic eye disease,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development at Roche. “We are committed to the treatment of serious eye diseases for patients with diabetes and pleased the FDA is moving forward in its consideration of Lucentis for diabetic retinopathy.”

Diabetic retinopathy is the most common diabetic eye disease and the leading cause of new cases of blindness in working-age Americans.¹ It is caused by changes in the blood vessels of the retina, the light-sensitive tissue at the back of the eye necessary for good vision. In its early stages, diabetic retinopathy is often without symptoms. Nearly 29 million Americans are living with diabetes. The longer a person has diabetes, especially if it is poorly controlled, the higher the risk for developing diabetic retinopathy. Diabetic retinopathy eventually affects nearly all diabetes patients and can lead to blindness if left untreated.²

Priority Review designation is granted by the FDA to medicines that, if approved, would have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections (control group). Benefits of Lucentis treatment were maintained during year three of treatment. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.

Lucentis was the first FDA-approved medicine for diabetic macular edema (DME), a major cause of vision loss in people with diabetic retinopathy. It was approved August 10, 2012 based on the RISE and RIDE trials.

References

1. Prevent Blindness America Prevalence of Adult Vision Impairment and Age-Related Eye Disease in America. Available at: http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html
2.  [CDC] Centers for Disease Control and Prevention. National diabetes Statistics Report, 2014. U.S. Department of Health and Human Services, Centers for Disease Sham and Prevention [resource on the internet; updated 2014; cited 2014 June 11]. Available at: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf