December 16, 2014
By Mark Terry, BioSpace.com Breaking News Staff
South San Francisco-based Genentech announced yesterday it had been granted by the U.S. Food and Drug Administration (FDA) breakthrough therapy designation for Lucentis (ranibizumab) for the treatment of diabetic retinopathy. Since the drug’s initial approval in 2006, the treatment for diabetic retinopathy would be the fourth approval.
“Diabetes is the leading cause of vision loss in working aged Americans,” said Jason Ehrlich, Genentech’s group medical director of ophthalmology, in a statement. “Genentech has a strong commitment to patients with diabetic eye disease and we are gratified that FDA has recognized Lucentis with this breakthrough therapy designation in diabetic retinopathy.”
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor. It is designed to bind to and inhibit VEGF-A, a protein that apparently plays a key role in the formation of new blood vessels. The drug has been approved by the FDA for the treatment of wet age-related maculardegeneration (wet AMD), macular edema after retinal vein occlusion (RVO), and diabetic macular edema (DME).
At this time there are no drugs approved for treatment of diabetic retinopathy. The condition affects around 7.7 million people in the U.S.
On Oct. 8, Genentech announced that the it had filed a supplemental Biologics License Application (BLA) with the FDA and been granted Priority Review of Lucentfor the treatment of diabetic retinopathy. Priority Review status is given by the FDA to compounds that, if approved, have the potential to have major improvements in the safety or effectiveness of treatment, diagnosis or prevention of serious conditions compared to standard treatments.
Lucentis was the first FDA-approved compound for diabetic macular edema (DME), approved in Aug. 10, 2012, based on the RISE and RIDE trials.
It comes with some controversy. When Lucentis was first marketed in 2006, it was set up to replace Genentech’s Avastin, which at that time cost about $50 per dose. Lucentis cost about $2,000 per dose. Avastin was actually a cancer drug, but essentially does the same thing as Lucentis, which was approved specifically to treat wet macular degeneration.
The drug did very well in the market, generating about $1 billion in Medicare expenses. However, a new federal database indicates that about 50 percent of the 20 physicians who received the most money to promote Lucentis in 2013 were also the doctors most likely to prescribe the medication. Those physicians earned $8,500 to $37,000 over a five-month period in 2013 in speaking and consulting fees, as well as travel expenses and meals.
