FDA Grants Priority Review for Genentech's Lucentis in Diabetic Retinopathy
South San Francisco, Calif. -- October 8, 2014 --
Genentech, a member of the Roche Group (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. "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.
About RISE and RIDE
RISE and RIDE are two identically-designed, parallel, double-masked, sham treatment-controlled trials in 759 patients with diabetic retinopathy and DME at baseline who were randomized into three groups to receive monthly treatment with 0.3 mg Lucentis, 0.5 mg Lucentis or sham injection. The primary objective of the RISE and RIDE trials was to evaluate the safety, tolerability and efficacy of Lucentis in DME patients as measured by the primary efficacy endpoint of percentage of subjects gaining ≥ 15 letters in best corrected visual acuity (BCVA) score compared with baseline at 24 months.
The efficacy of Lucentis for the treatment of diabetic retinopathy was also assessed over three years in RISE and RIDE patients with baseline diabetic retinopathy severity scores ranging from 10 to 75 in the study eye (on the ETDRS diabetic retinopathy severity scale). At Month 24, an exploratory analysis demonstrated a higher proportion of patients treated with Lucentis had observed a three-step or more improvement of their disease compared to sham, as determined by color fundus photography. In the third year of the studies, patients from the control group had the option to cross over to receive monthly treatment with 0.5 mg Lucentis; patients originally randomized to 0.3 mg or 0.5 mg Lucentis continued to receive their assigned dose and patients were followed for 12 additional months. The benefits of Lucentis treatment achieved at Month 24 were maintained through Month 36.
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. Lucentis is FDA-approved for the treatment of wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). Genentech has conducted eight key clinical trials with Lucentis. The medicine has been studied in 21 clinical trials worldwide in more than 9,000 patients.
Lucentis was developed by Genentech. The company retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.
Outside the U.S., Lucentis is approved in more than 100 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).
Lucentis Important Safety Information
Lucentis is a prescription medication given by injection into the eye, and it has side effects. Some Lucentis patients have had detached retinas and serious infections inside the eye. Patients should not use Lucentis if they have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.
Uncommonly, Lucentis patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes.
Some patients have had increased eye pressure before and within one hour of an injection.
Serious side effects include inflammation inside the eye and, rarely, problems related to the injection procedure, such as cataracts. These side effects can make vision worse.
The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common non-eye-related side effects are nose and throat infections, headache, lung/airway infections, and nausea.
If the eye becomes red, sensitive to light, or painful, or if there is a change in vision, patients should call or visit an eye doctor right away.
Lucentis is for prescription use only.
For additional safety information, please see Lucentis full prescribing information, available here: http://www.gene.com/download/pdf/lucentis_prescribing.pdf
About Genentech in Ophthalmology
Genentech's vision for ophthalmology is to bring innovative therapeutics to patients with eye disease. Currently, the company is investigating proprietary platforms for sustained drug delivery through an ocular implant and has also initiated clinical trials for patients with a specific biomarker who have geographic atrophy (GA), an advanced form of dry AMD. Additional focus includes working with bispecific molecules to simultaneously address multiple eye disease targets, and leveraging previous research in related therapeutic areas to develop new treatments for vision-threatening conditions.
Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche
Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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
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