ZURICH (Reuters) – Novartis launched an
external review on the safety of its Beovu blindness drug after the American
Society of Retina Specialists (ASRS) expressed concern.
Shares of the Swiss drug manufacturer fell almost 3% in the first operations after ASRS informed its members about the drug, a replacement for Novartis sales success, Lucentis.
Since the approval of Beovu last October, ASRS
has received reports of 14 cases of vasculitis, an inflammation of the blood
vessels, of which 11 were designated occlusive retinal vasculitis, an
inflammatory eye condition that threatens vision.
Novartis said he was aware of the recently reported adverse effects of the drug, adding that “it supports the safety and efficacy of Beovu.”
“In addition to our own internal assessment, we have hired an external safety review committee (SRC) to further evaluate these post-marketing cases. We will continue to share details as they become available,” the company said.
About 46,000 Beovu injections have been administered so far, Novartis said. The US Food and Drug Administration. UU. I was aware of the review, while the company now informs other health authorities.
Source: News Dio