In Addition, the Three New Beovu Lawsuits Filed for Patients with Vision Loss May Further Impact Novartis Market Share
(Posted by Tom Lamb at Drug Injury Watch)
Since being approved by the FDA in 2019, Beovu (brolucizumab) has been associated with vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation. In turn, during 2020 these Beovu side effects caused some eye doctors to avoid using Beovu injections for treatment of neovascular (wet) age-related macular degeneration (AMD). Now, at the start of 2021, Beovu lawsuits have been filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to adequately warn doctors and patients about serious Beovu side effects.
We start with a "snap-shot" of where things stood a month ago for Beovu, before the three recently filed Beovu drug injury lawsuits. From this December 15, 2020 news article, "Beovu's success in Kestrel is unlikely to fly in the real world", by reporter Lisa Urquhart for Evaluate Vantage, we get the following:
Novartis is now two for two with its pivotal trials of Beovu in diabetic macular oedema, following positive results from the Kestrel study. In the 571-patient trial a 6mg dose of the single-chain antibody fragment was non-inferior to 2mg of Regeneron/Bayer's Eylea in terms of baseline changes in best corrected visual acuity. The trial confirms the results seen in the Kite study, and also showed that Beovu could be used with a three-month dosing schedule. However, Novartis’s success here is unlikely to turn the tide on Beovu’s disappointing launch. The product, which is marketed for wet age-related macular degeneration, has been beset by serious safety concerns including severe intraocular inflammation and sight-threatening occlusive retinal vasculitis that has seen not only a revision to its label, but several class action lawsuits. Beovu’s side-effects have caused physicians to avoid the drug for safer options and sales forecasts to crash. Any chances of Novartis capturing market share are also likely to be further impacted by the patent expiry of Lucentis, expected next year, while the market is also bracing for Eylea biosimilars in 2024.
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A possible indication of the Novartis strategy for battling back from this less-than-ideal current posture can be found in a "Novartis Fourth Quarter and Full Year 2020 Condensed financial report – Supplementary Data" document:
Post marketing cases termed as “intraocular inflammation.” and/or “retinal vascular occlusion” that may result in severe vision loss, typically associated with intraocular inflammation and the current COVID-19 situation had an unfavorable impact on sales. Novartis has a comprehensive plan, in strong collaboration with leading external global experts to educate the retina community about the positive benefit / risk profile of Beovu. [See p. 12 of the 70-page PDF.]
We presume this Novartis plan to resurrect Beovu and get it back on its intended path of being a so-called "blockbuster" drug for Novartis in terms of sales involves its external safety review committee (SRC). In the past, Novartis has implied that this panel of experts was set up to provide an independent review of the Beovu side effects case reports. We reported on the most recent Novartis SRC findings made available to the public in this November 17, 2020 article, "Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections".
But one wonders what effect new Beovu lawsuits filed on behalf of individual patients who suffered severe loss of vision after receiving Beovu injections will have on eye doctors and AMD patients, alike. The first three of those Beovu lawsuits against Novartis (of which we are aware, at least) were filed during the past couple of weeks, with more to follow.
Given the serious nature and number of Beovu side effects reported to date, together with the Beovu lawsuits filed against Novartis for patients with vision loss, it seems fair to say that things look a bit grim for Beovu and Novartis at the present time.
Our law firm is investigating possible Beovu lawsuits for patients who have suffered vision loss or blindness due to Beovu side effects. If we can be of assistance to you or someone else regarding a Beovu drug injury case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.
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