ZURICH – Novartis has begun an external review after the American Society of Retinal Specialists (ASRS) raised concerns regarding the safety of its blindness medicine Beovu.
Novartis’ shares dropped 3% after the ASRS raised concerns regarding the Beovu drug, a replacement for the blockbuster Lucentis.
Beovu was approved last October, with a go-ahead from Europe earlier this month. The ASRS received reports of 14 vasculitis cases of which 11 were a sight-threatening inflammatory eye condition called occlusive retinal vasculitis.
Novartis claimed that it was aware of the drug’s adverse effects stating that it was 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.”
– Novartis
So far, approximately 46,000 Beovu injections have been administered and the U.S. Food and Drug Administration is aware of the review and 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
Beovu injections were used as a treatment for age-related wet macular degeneration. The condition affects over 20 million people globally and can eventually lead to blindness.
(Photos syndicated via Reuters)
This story has been edited by BH staff and is published from a syndicated field.