Roche Holding AG (ROG)’s Lucentis won the backing of U.S. regulatory advisers for expanded use to treat a leading cause of blindness associated with diabetes.
A Food and Drug Administration advisory panel voted at a meeting today to recommend the agency approve a 0.5 milligram and 0.3 milligram dose of Lucentis to treat diabetic macular edema. The FDA is supposed to decide whether to clear wider use of the drug next month and doesn’t have to abide by the panel.
Lucentis, if approved, would be the first drug cleared for diabetic macular edema. More than 500,000 people in the U.S. have the disease, Anthony Adamis, vice president and global head of ophthalmology at Basel-Switzerland-based Roche’s Genentech unit said in a telephone interview.
“I’m very excited,” Susan MacDonald, a panel member and director of comprehensive ophthalmology at the Lahey Clinic Medical Center in Peabody, Massachusetts, said during the meeting. “Having had patients go blind and not having had a way to treat them, this is a very big moment.”
The existing option for patients is to receive laser therapy. In addition to Roche’s Lucentis injection, Tarrytown, New York-based Regeneron Pharmaceuticals Inc. (REGN:US) is studying its Eylea drug to treat the condition.
Lucentis brought in $1.7 billion for Roche last year, according to data compiled by Bloomberg. Alimera Sciences Inc. (ALIM:US), based in Alpharetta, Georgia, and Psivida Corp. (PSDV:US) also are developing a diabetic macular edema treatment known as Iluvien. The FDA has twice rejected Iluvien, most recently in November.
The FDA pooled results from two Roche clinical trials and found 39 percent of patients who used the 0.3 milligram dose were able to read three additional lines of letters on an eye chart after two years compared to 41 percent who had the same effect on the 0.5 milligram dose, according to an FDA staff report released July 24.
Genentech recommended approval of the 0.3 milligram dose in its application to the FDA since there isn’t evidence of additional benefit of the higher dose, Terence Hurley, a spokesman for the company, said in an e-mail.
Patients who received the monthly injection also were significantly more likely than those who received fake doses of the drug to achieve 20/40 vision, enough eyesight to drive.
Lucentis and Eylea are drugs known as anti-vascular endothelial growth factors. Roche’s cancer drug Avastin also is an anti-VEGF treatment doctors commonly use to treat wet age- related macular degeneration even though it doesn’t have FDA approval for the disease. While drugmakers can’t promote medicines for uses they aren’t approved for, physicians can prescribe them for indications not on the label.
Lucentis costs 40 times as much as Avastin. Sixty percent of Medicare beneficiaries with macular degeneration received Avastin in 2008, Philip Rosenfeld, an ophthalmology professor at the University of Miami’s Miller School of Medicine, told a Senate committee a year ago. The repackaging of Avastin for the eye disease was linked in September 2011 to eye infections, some of which resulted in blindness.
Medicare payment advisers determined in March that anti- VEGF treatments improve health outcomes and said they didn’t have enough evidence to judge between the drugs.
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