The US Food and Drug Administration (FDA) approved a label update for brolucizumab (Beovu, Novartis) that will include additional safety information regarding retinal vasculitis and retinal vascular occlusion after receiving postmarketing reports of these conditions in 14 patients who received the drug, according to a company news release.
Brolucizumab is a humanized single-chain antibody fragment that is given by injection to treat wet age-related macular degeneration (AMD). The FDA approved brolucizumab for wet AMD on October 8, 2019. The European Commission authorized brolucizumab for the condition on February 17, 2020, after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended it on December 19, 2019.
The FDA's label update will add a subsection about retinal vasculitis and/or retinal vascular occlusion in its warnings and precautions section. The additional information explains "that these adverse reactions are part of a spectrum of intraocular inflammation rates from the Phase III HAWK & HARRIER trials," Novartis explains.
The FDA based its approval on results of the phase 3 HAWK & HARRIER trials, which found that brolucizumab was noninferior to aflibercept for mean change in best-corrected visual acuity at 1 year (week 48). Most patients were able to receive the drug for 3 months immediately after completing the loading phase of the study.
In early 2020, Novartis began an internal review after receiving "rare post-marketing reports of vasculitis, including retinal occlusive vasculitis." As part of that review, the company established an "external Safety Review Committee (SRV) to provide an independent, objective review of these cases and a comparison with select intraocular inflammation events" that also occurred in the two trials.
The review found similar overall rates of vision loss in the two studies' brolucizumab and aflibercept groups "despite the risk of vision loss associated with the adverse events of interest," the company explains in its news release.
"This label update provides clinicians with important information to guide treatment decisions. We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile," Marcia Kayath, global head of medical affairs and chief medical officer, Novartis Pharmaceuticals, said in the news release.
"We remain grateful to all doctors who have taken the time to share their expertise and treatment experience to contribute to the collective understanding of these safety events. As we proceed to examine root causes and potential mitigation strategies, we will continue to communicate findings with transparency and urgency to regulatory bodies and healthcare providers."
Physicians should continue to report any adverse or suspicious events in accordance with local requirements on the Novartis website. Updates on brolucizumab can be found on the product website.
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Cite this: FDA Approves Added Safety Info for Brolucizumab (Beovu) Label - Medscape - Jun 16, 2020.
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