A September 2020 announcement by Novartis about recent Beovu study results had an emphasis on the safety of Beovu. However, this is understandable in view of a February 2020 notification issued by the American Society of Retina Specialists (ASRS) which raised questions about the safety of Beovu.
We get the following from this September 14, 2020, Fierce Pharma article, “Novartis, stressing Beovu safety, matches Eylea in head-to-head diabetic macular edema trial”, about that Novartis announcement about a Phase 3 Beovu study:
Normally, late-stage trial announcements center on a drug’s efficacy, but Novartis singled out Beovu’s safety performance in its statement. Beovu demonstrated a safety profile comparable to Eylea’s, including the rate of intraocular inflammation, the company noted….
The intraocular inflammation safety signal led to an update to Beovu’s U.S. and [European Union (EU)] labels, which now include information about retinal vasculitis and retinal vascular occlusion, which can cause blindness. To better understand the problem, Novartis has put together a panel of experts from both within and outside the company to examine its root cause, potential risk factors and mitigation measures.
For information concerning the September 2020 European Beovu label change, you may want to look at this Novartis press release: “European Medicines Agency (EMA) approves safety label update for Novartis Beovu®”.
As background, Novartis had been counting on Beovu to challenge market-leading Eylea, but the ASRS Beovu alert was a set-back for Novartis. The financial consequence of this concern about the safety of Beovu was explained in an August 2020 Reuters news report as follows: “[Novartis Chief Executive Vas Narasimhan said in an interview that he] believes safety problems that emerged with new eye medicine Beovu have cost Novartis shares 10% of their value.”
Of course, we will continue to watch for more new developments related to the safety of Beovu.[View article in full at original source]