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Update: Brolucizumab’s Safety Under Review

Discussion in 'General Discussion' started by In Love With Medicine, Mar 3, 2020.

  1. In Love With Medicine

    In Love With Medicine Golden Member

    Jan 18, 2020
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    In a press release dated March 2, Novartis stated that more than 57,000 brolucizumab vials have been shipped to prescribing US physicians. To date, the drug's safety data "continue to support a favorable benefit-risk profile for Beovu."

    Their preliminary assessment of clinicians’ reports suggests that most cases present after the first or second injection, with patients reporting changes in vision, floaters, or blurry vision within 1 to 2 weeks of treatment. The company believes the incidence of these events remains consistent with or below the package insert: 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion. They reiterated that the incidence of vision loss in registration trials was comparable between brolucizumab and aflibercept.

    Physicians should advise patients to seek immediate care from an ophthalmologist should their eye become red, sensitive to light and painful or if vision changes occur in the days following brolucizumab administration, the company concluded.

    THIS IS A NEWS UPDATE. The earlier story follows below:

    Novartis has launched a safety review of their new anti-VEGF agent brolucizumab (Beovu) following reports of possible unintended side effects after the drug was approved last October.

    The move comes on the heels of a recent alert issued by the American Society of Retinal Specialists (ASRS) to its members concerning 14 reported cases of vasculitis after brolucizumab injections. Of those, 11 were designated as occlusive retinal vasculitis.

    The Swiss-based pharmaceutical giant “stands behind the safety and efficacy of Beovu,” they told Reuters on February 25. In addition to launching their own internal assessment, they have engaged an external safety review committee to investigate these post-approval cases. The FDA and other health authorities are or will be made aware of their plans, the company stated.

    “Our clinical development and pharmacovigilance teams are working with healthcare professionals to quickly obtain and evaluate all available information in order to classify these events and identify potential risk factors,” Novartis said.

    Results from a pair of phase 3 trials comprising 1,817 patients showed brolucizumab was generally well tolerated and did not report vasculitis as an adverse event. Investigators did, however, observe 16 cases of uveitis and 9 cases of iritis in brolucizumab-treated eyes; 90% were deemed mild to moderate and resolved with topical corticosteroids/anti-infectives. In addition, a few cases of conjunctivitis were noted in the paper, which was published in the January 2020 issue of Ophthalmology.

    Although serious ocular events were rare—no event occurred in more than 1% of eyes—the authors of the study noted there were more serious cases of uveitis (6 vs 0 eyes) and endophthalmitis (6 vs 0 eyes) with brolucizumab than aflibercept. Other serious adverse events that were observed in brolucizumab-treated eyes included vitritis, retinal artery thrombosis, retinal depigmentation, retinopathy proliferative and anterior chamber inflammation.

    Physicians should report any observed or suspected adverse events to the FDA's MedWatch Adverse Event Reporting as well as to Novartis.


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