Novartis released the following statement in response to an inquiry by Retina Specialist Magazine regarding the American Society of Retina Specialist update posted Feb. 23 regarding reports of inflammation and vasculitis related to Beovu (brolucizumab):
Patient safety is of paramount importance for Novartis. On February 23, 2020, the American Society of Retina Specialists (ASRS) shared with its membership that since Beovu approval on October 7, 2019, ASRS has received reports of 14 cases of vasculitis, of which 11 were designated by the reporting provider as occlusive retinal vasculitis.
Of note: Novartis’ review of this information is ongoing and classification of these ASRS-reported cases by Novartis has not been established but we are aware of recently reported adverse events following treatment with Beovu.
Novartis 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.
An estimated 46,000 injections have been administered in the US as of February 21, 2020. 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.
Beovu is contraindicated for patients with active intraocular inflammation. Physicians should follow the guidance in the prescribing information that patients with active inflammation should not be injected with Beovu. The product information leaflet for Beovu in the US states a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion.
Please report any observed or suspected adverse events to Novartis at 1-888-NOW-NOVA (1-888-669-6682) or the FDA via MedWatch.
