ZURICH (Reuters) - Novartis has launched an external review into the safety of its blindness medicine Beovu after the American Society of Retinal Specialists (ASRS) raised concerns.
The Swiss drugmaker’s shares fell nearly 3% in early trading after the ASRS communicated to its members about the drug, a replacement for Novartis’ blockbuster Lucentis.
Since Beovu’s approval 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 - a sight-threatening inflammatory eye condition.
Novartis said it was aware of recently reported adverse effects of the drug, adding it “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,” the company said.
Around 46,000 injections of Beovu have so far been administered, Novartis said. The U.S. Food and Drug Administration was aware of the review, while the company is now 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,” Novartis said.
The company received approval from the FDA for Beovu in October and the go-ahead in Europe earlier this month.
Beovu injections are used to treat wet age-related macular degeneration, a condition which can eventually lead to blindness and affects around 20 million people worldwide.
Reporting by John Revill; editing by Jason Neely, Kirsten Donovan