The US Food and Drug Administration has approved a label update for brolucizumab (Beovu), to include additional safety information regarding retinal vasculitis and retinal vascular occlusion. According to the drug sponsor (Novartis), the update includes characterization of adverse events “as part of the spectrum of intraocular inflammation observed in the HAWK & HARRIER trials and noted in the original prescribing information”. In February, the American Society of Retina Specialists (ASRS) had earlier issued a safety update to clinicians detailing 14 cases of retinal vasculitis and vascular occlusion.
On June 11, Novartis has approved the company to “pursue worldwide label updates after a review and further characterization of rare post-marketing safety events reported”. The update to the US label includes the addition of a sub-section dedicated to retinal vasculitis and/or retinal vascular occlusion under ‘Warnings and Precautions’ (section 5). Novartis also specifies that these adverse reactions are part of a spectrum of intraocular inflammation rates from the Phase III HAWK & HARRIER trials. According to the company, Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis stated that, “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. 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.” The NovartisSafety Review Committee (SRC) for the update was available at www.brolucizumab.info
Beovu was approved in the US in October 2019 and on February 13th 2020 iby the EMA for the treatment of wet age-related macular degeneration (AMD), based on findings from the Phase III HAWK and HARRIER clinical trials. Known as RTH258, the drug is a clinically advanced humanized single-chain antibody fragment (scFv). The molecule is a 26 kDa with inhibition of, and high affinity to, all VEGF-A isoforms. The antibody inhibits activation of VEGF receptors through prevention of the ligand-receptor interaction. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability. In clinical studies, brolucizumab demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one (week 48). The drug demonstrated the ability to maintain a majority of patients on a three-month interval immediately after the loading phase.