Date: 2017-04-18
Type of information: Granting of a Market Authorisation in the US
Product name: Lucentis®
Compound: ranibizumab
Therapeutic area: Ophtalmological diseases - Metabolic diseases
Action mechanism: monoclonal atibody. Lucentis® is a recombinant humanized monoclonal antibody fragment (lacking a Fc region). Lucentis® is the first VEGF inhibitor specifically designed for use in the eye 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.
Company: Genentech (USA), a member of Roche Group (Switzerland)
Disease: diabetic retinopathy
Latest news:
- • On April 18, 2017, the FDA has approved Lucentis® (ranibizumab injection), 0.3 mg for the monthly treatment of withal forms of diabetic retinopathy. With this approval, Lucentis® becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye.
The FDA granted Lucentis® Priority Review for the treatment of diabetic retinopathy without DME based on an analysis of the Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study. This NIH-funded study compared Lucentis® treatment to panretinal laser treatment in diabetic retinopathy patients both with and without DME. In the Lucentis® group, patients received a baseline 0.5 mg intravitreal injection followed by three monthly intravitreal injections, after which treatment was guided by pre-specified re-treatment criteria. In the analysis that supported the approval, 37.8 percent (n=56/148) of patients in the Lucentis® group without baseline DME had a two-step or better improvement in their diabetic retinopathy and 28.4 percent (n=42/148) had a three-step or better improvement at two years, according to the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS).
In Lucentis®-treated patients with baseline DME, 58.5 percent (n=24/41) had a two-step or better improvement in their diabetic retinopathy and 31.7 percent (n=13/41) had a three-step or better improvement at two years. Adverse events were similar to those seen in other Lucentis® trials.
- • On February 6, 2015, Genentech announced that the FDA approved Lucentis® (ranibizumab injection) for the treatment of diabetic retinopathy in people with diabetic macular edema. The FDA granted Lucentis® Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials. In 2012, Lucentis was the first medicine approved by the FDA for the treatment of diabetic macular edema. Lucentis has also been an important option for patients with wet age-related macular degeneration (wet AMD) since 2006 and macular edema following retinal vein occlusion (RVO) since 2010.
- • On October 8, 2014, Genentech announced that the 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. 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. 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. 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® 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.
- • On August 8, 2014, Genentech announced that the company has submitted a supplemental Biologics License Application (sBLA) for Lucentis® (ranibizumab injection) to the FDA for the treatment of diabetic retinopathy. The submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis® for this serious eye disease. There are currently no ocular medications approved for the treatment of diabetic retinopathy. Diabetic retinopathy 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. During the RISE and RIDE trials, a clinically significant proportion of diabetic retinopathy patients treated with Lucentis showed meaningful improvements in their disease at two years compared to patients treated with sham injections (control group). The benefits of Lucentis® on the signs of diabetic retinopathy were maintained during the third year of treatment.
- 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 safety and efficacy of Lucentis® for the treatment of diabetic retinopathy was assessed over three years in patients with baseline diabetic retinopathy severity scores ranging from 10 to 75 in the study eye (on the ETDRS diabetic retinopathy severity scale). Primary outcomes were evaluated at 24 months. At Month 24, a higher proportion of patients had observed a three-step improvement or better 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 the same dose and all patients were followed for 12 additional months.
Patents:
Submission of marketing authorization application USA : 2014-08-07
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2015-02-06/2017-04-18
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
