Novartis launches review of Beovu after safety concerns, says report

Novartis has reportedly initiated an external review into the safety of its drug Beovu, intended for the treatment of wet age-related macular degeneration (AMD). The decision comes following concerns voiced by the American Society of Retinal Specialists (ASRS), according to Reuters. 

The outlet reports that since the Beovu was approved in October 2019, ASRS has received reports of 14 cases of vasculitis, an inflammation of the blood vessels, of which 11 were designated occlusive retinal vasculitis – a sight-threatening inflammatory eye condition.

The pharmaceutical company has said it is aware of recently reported adverse effects of the drug, depsite cliaiming that it “stands behind the safety and efficacy of Beovu,” as quoted by the outlet. “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 US Food and Drug Administration (FDA) is purportedly aware of the review, while Novartis now informs 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,” Novartis said, as relayed by Reuters.