Novartis confirms that Beovu has an adverse event or faces a black box warning!

In October 2019, Novartis ophthalmology innovation drug Beovu (brolucizumab) was approved by the U.SFDA for the treatment of wet age-related macular degeneration (wet-AMD)The drug is a new generation of antivascular endothelial growth factor (VEGF) drugs that combine multiple rings, such as the first anti-VEGF drug that can be treated at 3 month intervals without affecting efficacy, the first anti-VEGF drug that performs better than Eylea but performs better in reducing retinopathythere are currently two heavy-duty eye products on the market, Eylea and Lucentis, but both face the expiration of patents in 2020, after which biosimilars could eat into the market at low pricesHowever, the industry remains bullish on Beovu's prospectsSome analysts expect Beovu's annual sales peak to top $1 billion and are expected to dominate the wet-AMD market by 2026However, a report released by the American Society of Retinal Specialists (ASRS) in late February casts a shadow over Beovu's prospectsThe report notes the need to pay close attention to reports of vasculitis and other complications that can lead to loss of vision, which it considers to be a potential side effect of Beovu treatmentASRS cited 14 cases of vasculitis, 11 of which were designated as obstructive retintenteritis, an inflammatory disease that is determined to threaten vision, according to a New York Times report at the timeAnalysts say the ASRS report will cause many ophthalmologists in the U.Sto be "crazy" about Beovu's side effects, as as many as 46,000 Beovu have been injected in the U.Ssince its launch in Februaryafter ASRS raised these concerns, Novartis said it would work with the External Security Review Board to assess the post-marketing cases of the ASRS report in order to classify these incidents and identify potential risk factorsrecently, Novartis confirmed that Beovu does have the above therapeutic side effectsIn March, the company reported 10 blocked arteries, inflammation of blood vessels or severe vision loss for every 10,000 injectionsSpecifically, in a recent review of post-market adverse events reports, Novartis found that in the five weeks from February 28 to March 27, there were 8.75-10.08 occurrences of retinal artery obstruction, inflammation of the eye' blood vessels, or severe vision loss per 10,000 injectionsEvents leading to severe vision loss (vyreitis or cataracts are most common) occur as much as 4.03 per 10,000 injections during the week of 6 March RBC Capital Markets analyst Kennen MacKay said cases of severe vision loss and vasculitis should be subject to the most rigorous FDA scrutiny because they have not been reported to be related to the use of Eylea and other anti-VEGF drugs, such as Lucentis and Avastin, which are hyperlabeled in ophthalmology treatment Novartis, the , said it would work with regulators in the United States, Europe and other countries to revise Beovu's product labels to increase new safety information and change ongoing clinical trials to prevent such adverse events Research investigators will need to inform trial participants of the risks of these new findings and continue the trial with their consent Kennen MacKay, a , predicts that these adverse events in Beovu could lead to black-box warnings and could severely limit Beovu's market penetration in the U.S., the Black Box Warning is one of the most serious warnings the FDA has taken on drugs on the market, appearing at the top of the instructionmanual, displayed with a bold black border, designed to alert physicians and patients to potentially significant safety issues during drug use reference source: 1, Eye drug side effects are real, Novartis s confirm in new warning 2, Novartis Shares Fall Follow-Up Post-Marketing Concerns Over AMD Drug Beovu