Key Events for Beovu 2019 - 2020: FDA Approval, Safety Alerts and Warnings, Drug Label Changes, Novartis Investigation
Leading up to the October 2019 launch of Beovu here in the US, Novartis was hoping its new age-related macular degeneration (AMD) drug would compete with Eylea and Lucentis, which were more established AMD drugs. But then came the unwanted Beovu adverse drug reactions and Beovu-related eye problems, with numerous reports of Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.
In this article, we walk you through the key events for Beovu in 2019 and 2020 that seem to have moved Beovu away from being a blockbuster AMD drug for Novartis and toward the possibility of there being a Beovu drug recall in 2021.
To start, Beovu was approved by the FDA on October 7, 2019, for the treatment of wet age-related macular degeneration (AMD).
From the outset, this launch of Beovu in the US was a bit rocky for Novartis, as seen by this excerpt from an October 8, 2019, Fierce Pharma piece, "Novartis takes on Regeneron, Roche blockbusters with Beovu approval":
The drug won approval for 8- and 12-week dosing intervals after a three-month loading phase of monthly injections. But SVB Leerink analysts pointed out that the label carries “higher safety liabilities” than Eylea. In the phase 3 trials, patients on Beovu were four times as likely to have intraocular inflammation than those on Eylea, at 4% and 1%, respectively.
Then on February 23, 2020, the 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, as reported by this news report, "Novartis' hot new eye drug Beovu tied to potential vision loss: experts".
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Battling back, a week later Novartis stated the current prescribing information document for Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion. You can read more about that position in this March 2, 2020, article, "Novartis stands behind Beovu's safety, benefits after vision-loss warning".
About a month later, however, we saw this April 6, 2020, BioPharmaDive item, "Eye drug side effects are real, Novartis confirms in new warning", reporting 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-related eye problems.
Next, as announced in this June 9, 2020 Supplemental Approval letter, 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 vision loss and blindness.
This was followed a few months later by the September 14, 2020, Novartis Media Release item, "European Medicines Agency (EMA) approves safety label update for Novartis Beovu®".
And lastly, there is this November 14, 2020 Reuters news report, "Novartis identifies possible risk factors for Beovu patients". Summarily it let us know that, according to a safety review issued by Novartis, the main risk of experiencing Beovu adverse drug reactions such as retinal vasculitis and/or retinal vascular occlusion within the six months after the first administration of Beovu was prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu.
We will watch for further developments concerning these various Beovu adverse drug reactions and Beovu-related eye problems, as well as indications of a possible Beovu drug recall in 2021.
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