Recent Beovu Label Change in Europe Adds Information About Retinal Vasculitis and Retinal Vascular Occlusion

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In mid-September 2020 Novartis announced the results of a Phase 3 head-to-head study comparing its relatively new eye medicine Beovu to Eylea, a more well-established competing eye drug product from Regeneron. According to Novartis, this study shows that after one year of treatment Beovu matched Eylea in terms of the best-corrected vision acuity for patients with diabetic macular edema.

But what has been pointed out as a bit unusual about this recent Beovu study results announcement by Novartis is an emphasis therein 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.

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."

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Returning to the recent announcement about that Phase 3 study, 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":

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.

Close followers of the rivalry between the two anti-VEGF agents know that inclusion refers to a newly noted Beovu side effect that practically derailed the drug’s initial launch in age-related macular degeneration (AMD).

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.

Here is a Novartis press release about the September 2020 European Beovu label change: "European Medicines Agency (EMA) approves safety label update for Novartis Beovu®".

We reported on the FDA's Beovu regulatory action taken this past summer in this article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020".

We will continue to watch for news related to the safety of Beovu, and report significant developments here.

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