A week after the American Society of Retinal Specialists (ASRS) shared a note with its membership warning of vision-threatening cases of occlusive retinal vasculitis of wet AMD drug Beovu, Novartis issued a press release on Monday stating it stands behind the safety and efficacy of Beovu when used as indicated. Novartis said it believes the incidence of these events is consistent with the medicine’s package insert.
“As of March 2, 2020, more than 57,000 Beovu (brolucizumab) vials for injection have been shipped to prescribing physicians in the US1. To date, the safety data continue to support a favorable benefit-risk profile for Beovu,2,3” according to Novartis.
“As with all medicines, adverse events can occur, which is why we continuously monitor the safety of our products for the occurrence of such events. The prescribing information leaflet for Beovu in the US states a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion,” according to Novartis. “As of February 28, our global safety organization is conducting a comprehensive review of a limited number of reported cases of severe vision loss, inflammation and potential retinal vasculitis in patients treated with Beovu, including cases where patients had previously received other VEGF inhibitors. We believe the incidence of these events remains consistent with or below the package insert4. In the registration trials, the incidence of vision loss was comparable at all letter intervals across Beovu and aflibercept2,4.”
As previously reported, Novartis stated that as part of its safety surveillance program, the company is conducting a comprehensive product quality review and actively evaluating every case.
“We are working closely with the reporting physicians and retina specialists to collect the relevant clinical data and fully understand these events. Furthermore, we are engaging with the Data Monitoring Committee (DMC) for our ongoing global trials and have engaged an external Safety Review Committee (SRC) to further evaluate and advise on the post-marketing cases,” the news release read.
Novartis said the FDA, EMA, Swissmedic, Australian TGA, and other health authorities are aware of the review, and Novartis is in the process of informing other regulatory bodies.
“We commit to sharing the outcome of the review upon completion,” Novartis said.
On February 23, ASRS shared a note with its membership stating that since Beovu was approved on October 7, 2019, ASRS has received reports of 14 cases of vasculitis, of which 11 were designated by the reporting provider as occlusive retinal vasculitis, a vision-threatening inflammatory eye condition. An analysis from Jefferies, citing the FDA Adverse Event Reporting System (AERS) database, found that since Beovu’s launch in November, 36 serious cases have been reported to AERS, with two cases of vasculitis, six of blindness and four involving eye inflammation.
Novartis stated that while the review is ongoing and Novartis’ classification of these reported adverse events has not yet been established, clinicians’ reports suggest that most cases present after the first or second injection of Beovu with patients reporting changes in vision, such as significant increase in floaters or blurry vision, within one to two weeks of treatment.
“Based on these preliminary observations and consistent with the approved Beovu product labeling, Novartis reminds physicians to advise patients that in the days following Beovu administration, if the eye becomes red, sensitive to light, painful or develops a change in vision, they should seek immediate care from an ophthalmologist4,” according to Novartis.
Beovu is contraindicated in patients with active intraocular inflammation. Physicians are asked to report any observed or suspected adverse events to Novartis at https://www.report.novartis.com or +1-888-NOW-NOVA (1-888-669-6682) Monday – Friday, 8:30 am – 5:00 pm ET.
1. Data on File. Internal Sales Data. Novartis Pharmaceuticals Corporation. February 2020.
2. Dugel P, Koh A, Ogura Y, et al; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.
3. Data on file. RTH258 Clinical Study Report. Novartis; 2019.
4. Beovu [US prescribing information] East Hanover, NJ. Novartis: 2019.
5. Beovu [summary of product characteristics] Dublin, Ireland. Novartis: 2020.
6. Beovu [Swissmedic prescribing information] Switzerland. Novartis: 2020.
7. Beovu [prescription medicine decision summary] Australia. Novartis: 2020.