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FDA approves Novartis’ Beovu for wet AMD
The FDA has approved Beovu for the treatment of wet age-related macular degeneration, Novartis announced in a press release.
Beovu (brolucizumab-dbll), also known at RTH258, demonstrated noninferiority vs. aflibercept in the phase 3 HAWK and HARRIER clinical trials and is the first FDA-approved anti-VEGF to maintain wet AMD patients on a 3-month dosing interval after a 3-month loading phase, the release said.
“The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment,” Marie-France Tschudin, president of Novartis Pharmaceuticals, said in the release. “The product labels of existing treatments state that they are not as effective when dosed every 12 weeks. Beovu is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness. This gives more time for wet AMD patients to focus on what’s important in their lives.”
The company plans to offer Beovu Your Way, a program that will provide one-on-one support for patients and caregivers in the U.S.
Perspective
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The FDA’s long-anticipated approval of Beovu (brolucizumab, Novartis) provides a much desired anti-VEGF compound with FDA labeling for dosing every 12 weeks, unlike its predecessors, which were labeled for every 8 week dosing. Real-world experience will determine the actual frequency with which this medication is used when a “treat-and-extend” approach is taken, and the cost-benefit ratio will determine its place among other less expensive but off-label anti-VEGF agents such as Avastin (bevacizumab, Genentech). As anti-integrin and other agents also enter the market, one thing is certain: The treatment of wet AMD will change and benefit patients challenged by this disease.
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