Beovu Use Increased Risks Of Retinal Vasculitis And Retinal Vascular Occlusion, Which Can Lead To Blindness

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In early June 2020, the FDA approved a label update for Beovu (brolucizumab) whereby Novartis will add warnings and safety information about retinal vasculitis and retinal vascular occlusion, which can lead to loss of vision. This FDA regulatory action comes after postmarketing reports of these Beovu vision-loss side effects in 14 patients who received the wet age-related macular degeneration (wet AMD) drug.

From this June 12, 2020 news article, "Beovu Labeling Updated With Additional Safety Information", we get the following details:

The update is based on a recent internal review conducted by Novartis of adverse events observed in the HAWK & HARRIER clinical trials, including rare postmarketing safety reports of vasculitis. According to Novartis, a review of these postmarketing events concluded that “there is a confirmed safety signal of rare adverse events termed as ‘retinal vasculitis’ and/or ‘retinal vascular occlusion’ that may result in severe vision loss.” These events typically occurred when intraocular inflammation was present.

When compared with select intraocular inflammation events seen in the phase 3 trials, the Safety Review Committee (SRC) established by the Company found that cases similar to the postmarketing reports were present in these trials.

As background, the FDA approved Beovu for the treatment of wet AMD on October 8, 2019. The European Commission authorized Beovu for wet AMD on February 17, 2020, after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended it on December 19, 2019.

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Here is an excerpt from the June 9, 2020, FDA Beovu label change approval letter:

Please refer to your supplemental biologics license application (sBLA), dated and received May 11, 2020, and your amendments, submitted under section 351(a) of the Public Health Service Act for BEOVU (brolucizumab-dbll) injection. This Prior Approval supplemental biologics application provides for the addition of “Retinal Vasculitis and/or Retinal Vascular Occlusion” to the Warnings and Precautions section of the Prescribing Information.

From the new Beovu drug label, or "Full Prescribing Information (Revised: 6/2020)" document, here is the Beovu vision-loss side effect warning:

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU [see  Contraindications (4.2) and Adverse Reactions (6.1)]. Patients should be instructed to report any change in vision without delay.

We have been following developments regarding this Beovu drug-safety issue for the past few months, as seen by these recent Drug Injury Watch articles:

• Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report (April 9, 2020)
• Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings (March 4, 2020)
• Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug (February 27, 2020)

We are currently investigating drug injury lawsuits against Novartis for Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.

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