Novartis has launched a review into the safety of its anti-vascular endothelial growth factor (VEGF) inhibitor Beovu (brolucizumab) after safety concerns were raised by the American Society of Retinal Specialists (ASRS) earlier this year.
Since Beovu was approved by the US Food and Drug Administration (FDA) in October last year, the ASRS has received reports of 14 cases of vasculitis, with 11 documented as occlusive retinal vasculitis, a vision-threatening inflammatory eye condition. The ASRS voiced its concerns to members at the end of February, leading Novartis to issue a statement in March saying it stands by the safety and efficacy of Beovu but will conduct a comprehensive review into the “limited number” of adverse cases reported.
“The safety of Beovu has been demonstrated in an extensive Phase III programme, including more than 1,800 patients worldwide across 400 study sites,” said Novartis. “As with all medicines, adverse events can occur, which is why we continuously monitor the safety of our products for the occurrence of such events. The prescribing information leaflet for Beovu in the US states a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion.”
As well as conducting its own product safety quality review, Novartis has engaged an external safety review committee to further evaluate and advise on the post-marketing cases. Review results will be shared upon completion, said Novartis.