Novartis confirmed to Eyewire News that it is launching an internal and external review of new information that raises serious safety concerns over its wet age-related macular degeneration (AMD) drug Beovu (brolucizumab).
On February 23, the American Society of Retinal Specialists (ASRS) shared a note with its membership stating that since Beovu was approved 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, a vision-threatening inflammatory eye condition.
In a statement sent to Eyewire News, Novartis said it is aware of recently reported adverse events following treatment with Beovu and is currently evaluating the cases.
“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,” according to Novartis. “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.”
An estimated 46,000 injections of Beovu have been administered in the US as of February 21, 2020, according to Novartis.
The company added that Beovu is contraindicated for patients with active intraocular inflammation, and that 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.
Last week, Novartis received European Commission approval for Beovu, making it the first European Commission-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF) versus aflibercept (secondary endpoints).
The European Commission approval was based on findings from the phase 3 HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in best corrected visual acuity (BCVA) that were noninferior to aflibercept at year one (week 48). Vision gains at year 1 were maintained at year 2.
The European Commission decision is applicable to all 27 European Union member states, as well as the UK, Iceland, Norway and Liechtenstein.