Up-to-Date Timeline for Beovu: Approved by FDA | Safety Alerts & Warnings | Drug Label Changes | Novartis Investigation | Beovu Vision Loss Lawsuits
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This Beovu timeline sets forth the still-developing story about why Beovu lawsuits are being filed against Novartis, the manufacturer of Beovu, alleging this pharmaceutical drug company failed to adequately warn doctors and patients about Beovu side effects. In fact, the first two of these Beovu vision loss lawsuits were for clients of our law firm.
The points of interest included in this Beovu timeline are the discovery of Beovu side effects such as vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation, the announcement of Beovu drug safety warnings by FDA, the filing of Beovu vision loss lawsuits, and more. This timeline will be kept up to date as we learn more about this Beovu drug injury situation.
The information on this Beovu timeline web page is presented by the Law Offices of Thomas J. Lamb, P.A., for general information purposes only, and is not intended as a scientific authority or medical advice.
October 7, 2019 – Beovu approved by the FDA
Beovu is approved by the FDA to treat wet age-related macular degeneration.
Source: FDA Letter
February 23, 2020 – ASRS issues a note about Beovu-related cases of retinal vasculitis
Chicago-based American Society of Retinal Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis across 46,000 injections since Beovu’s launch.
Primary Source: Novartis’ plans to wrestle Eylea market share take a hit as Beovu is linked to safety concerns
Secondary Source: Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug
March 2, 2020 – Novartis claims current Prescribing Information documents are sufficient
Novartis stated the current prescribing information document for its macular degeneration drug Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion.
Primary Source: Novartis stands behind Beovu’s safety, benefits after vision-loss warning
Secondary Source: Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings
April 9, 2020 – Beovu label change revisions begin
Novartis said it would work with the FDA, the European Medicines Agency (EMA), and other drug safety regulators around the world to issue a revised Beovu drug label with new warnings about Beovu vision-related side effects.
Primary Source: Eye drug side effects are real, Novartis confirms in new warning
Secondary Source: Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report
June 9, 2020 – First Beovu label change approved by the FDA
In early June 2020, the FDA approved a label update for Beovu whereby Novartis will add warnings and safety information about retinal vasculitis and retinal vascular occlusion, which can lead to loss of vision.
Primary Sources: FDA Supplemental Approval Letter and Beovu Full Prescribing Information (Revised 6/2020)
Secondary Sources: Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020 and Beovu Label Change Approved After Confirmation of Rare Adverse Side Effects
August 4, 2020 – Novartis spokesman gives a status update on Beovu safety issues
In this four-minute video, a Novartis vice president discusses the company’s current approach to address Beovu safety issues relating to the occurrence of retinal vasculitis or retinal vascular occlusion associated with Beovu treatments.
Source: August 2020 Ocular Surgery News Article
September 14, 2020 – Beovu European Union (EU) label change
Novartis updated the EU label to include retinal vasculitis and/or retinal vascular occlusion under “Special warnings and precautions for use” and “Undesirable effect”. The label notes that patients developing these events should discontinue treatment and the events should be promptly managed.
Primary Source: European Medicines Agency (EMA) approves safety label update for Novartis Beovu
Secondary Source: Safety of Beovu: A Lingering Issue Which Novartis Attempts to Counter with Recent Study Results
November 14, 2020 – Novartis identifies certain pre-existing conditions as new risk factors
In a review issued by Novartis, the main risks for experiencing vision-altering side effects such as retinal vasculitis and/or retinal vascular occlusion within the six months after the first administration of Beovu are prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu.
Primary Source: Novartis identifies possible risk factors for Beovu patients
Secondary Sources: Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections and Pre-existing Eye Conditions Linked to Beovu-related Adverse Events
January 19, 2021 – The first two Beovu drug injury lawsuits are filed against Novartis
Starting in January 2021 Beovu lawsuits have been filed for patients alleging Novartis failed to warn doctors and patients about these Beovu side effects which can lead to severe vision loss and blindness.
On this day, the first two of these Beovu lawsuits, identified below, were filed on behalf of our law firm’s clients:
- Harris v. Novartis Pharmaceuticals Corporation (4:21-cv-03013)
United States District Court, D. Nebraska
- Cohen v. Novartis Pharmaceuticals Corporation (4:21-cv-03014)
United States District Court, D. Nebraska
May 28, 2021 – Novartis stops 3 Beovu clinical trials for safety reasons, and will update Beovu drug label
“In the interest of patient safety, Novartis has decided to terminate the MERLIN study and the RAPTOR and RAVEN studies, which were assessing the efficacy and safety of [Beovu (brolucizumab)]…. Novartis has proactively communicated these data to health authorities and will pursue an update to the Beovu prescribing information globally.”
Primary Source: Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program
Secondary Source: Beovu Vision Loss Side Effects Continue to Plague Novartis, Ending 3 Key Clinical Trials in May 2021
January 18, 2022 – Revised Beovu Product Information document provides “risk factors and possible mechanism” information
The first Beovu drug label change since Novartis said in May 2021 that the company “will pursue an update to the Beovu prescribing information globally” was previewed in a Novartis November 2021 “Dear Doctor” Letter about Beovu and announced in an MHRA January 2022 Drug Safety Update item for Beovu.
Primary Sources: Novartis November 2021 Beovu “Dear Doctor” letter and MHRA January 2022 Drug Safety Update item for Beovu
Secondary Source: Beovu Drug Label Change in December 2021 Adds More Information About Vision Loss Side Effects
February 18, 2022 – Second Beovu label change approved by the FDA
We had been watching for a forecasted Beovu label change since May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, and, at the same time, said it would update the Beovu drug label. Finally, in February 2022, Novartis added information and increased safety warnings about Beovu’s side effects, such as retinal vasculitis, retinal vascular occlusion, and retinal artery occlusion.
Primary Source: Drug Safety-related Labeling Changes (SrLC) for Beovu (brolucizumab-dbll)
Secondary Source: Novartis Finally Issues Revised Beovu Prescribing Information for US in February 2022
(Last Updated: 2/24/2022)
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