Reports in the New York Times and Eyewire News have indicated that Novartis has launched an internal review of information that raises serious safety concerns on the use of brolucizumab (Beovu), for AMD. In addition, according to the American Society of Retina Specialists (ASRS), there have been 14 cases of retinal vasculitis for Beovu patients a number of which may lead to vision complications. According to Novartis, the company “stands behind the safety and efficacy of Beovu. In addition to our own internal assessment, we have engaged an external safety review committee (SRC) to further evaluate these post-marketing cases. We will continue to share details as they become available. The FDA is aware of our ongoing review and we’re in the process of informing other health authorities. Our clinical development and pharmacovigilance teams are working with healthcare professionals to quickly obtain and evaluate all available information in order to classify these events and identify potential risk factors.”
The New York Times has commented that around 46,000 injections of Beovu have been administered and the U.S. Food and Drug Administration are currently aware of the review. Beovu (brolucizumab or RTH258) is a humanized single-chain antibody fragment (scFv) and, according to Novartis, the drug is a small molecule (26 kDa) targeting all VEGF-A isoforms inhibit the activation of VEGF receptors through prevention of the ligand-receptor interaction. Clinical trials had previously reported that approx. 1,800 patients demonstrated non-inferiority for Beovu versus aflibercept in mean change in BCVA for 12 months. According to studies, approximately 30% of patients treated with Beovu gained at least 15 letters. In addition, Novartis reported that Beovu exhibited an overall safety profile comparable to aflibercept with the most common adverse events being blurred vision, cataract, conjunctival hemorrhage, vitreous floaters and eye pain (≥5% of patients). The external safety review of the complication with vasculitis is awaiting their findings, in addition to a pending report from the FDA.