dm+d

38248111000001108

Refrigerated Storage

BeovuNovartis Pharmaceuticals

Novartis Pharmaceuticals
Beovu
Solution for injection

In the event of an inadvertent temperature excursion the following data may be used:
Prior to use, the unopened product may be kept at room temperature (below 25°C) for up to 24 hours.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

28 February 2022
London MI Service

New Medicines

BeovuDiabetic macular oedema

Information

Beovu
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Launched
Launched
Approved (Licensed)
April 2022
Jun 22 FDA approves brolucizumab for the treatment of diabetic macular edema (DME) [14]
Apr 22Approved in the UK. Licence extension "Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration" [13].
Apr 22Licence extension approved in EU [12].
Feb 22Recommended for EU approval by CHMP – the additional indication is “for the treatment of visual impairment due to diabetic macular oedema (DME)” [11].
Oct 21Filings in the EU and US have been accepted and regulatory decisions are expected mid-2022 [10]
Aug 21Filed in EU and US, using findings from KESTREL and KITE pivotal trials [9].
Jun 19Filings planned for 2021 [4].

Category

A humanised monoclonal single chain FV antibody fragment inhibiting vascular endothelial growth factor A (VEGF-A). Dosed four times a year.
In 2017-18 there were 3,196,124 registrations of diabetes mellitus in patients aged 17 years and older in England [1]. It is estimated that approximately 7% of people with diabetes have DMO which is about 223,729 of whom 87,254 (39%) have clinically significant macular oedema [2].
Diabetic macular oedema
Intravitreal

Further information

Yes

Trial or other data

Dec 21Novartis announced the first interpretable results from year 2 (week 100) of the PIII KESTREL study. Results were consistent with those seen at year 1, including maintenance of best-corrected visual acuity (BCVA) and sustained reductions in central subfield thickness (CSFT). Additionally, numerically fewer brolucizumab patients had intraocular fluid and/or sub-retinal fluid (IRF/SRF) vs patients treated with aflibercept. More than 40% of brolucizumab patients were maintained on 12-week dosing intervals, and 70% of patients who completed the first 12-week cycle after loading remained on 12-week dosing through year 2, showing the potential for brolucizumab to offer fluid resolution in more DME patients with fewer injections vs aflibercept. Rates of intraocular inflammation (IOI) were 4.2% for brolucizumab 6 mg, 5.3% for brolucizumab 3 mg and 1.1% for aflibercept; retinal vasculitis (RV) rates were 0.5% for brolucizumab 6 mg, 1.6% for brolucizumab 3 mg and 0% for aflibercept. Rates of retinal vascular occlusion (RO) were 1.6% for both brolucizumab 6 mg and 3 mg vs 0.5% for aflibercept. The majority of IOI events were manageable and resolved without any clinical complications [10].
Dec 20KESTREL study of Beovu demonstrated significant improvement in central subfield thickness in Diabetic Macular Edema (DME), re-affirming the positive topline results announced in September from pivotal KITE study.[8]
Dec 20PIII KESTREL and KITE studies are no longer recruiting. Positive topline results from KITE were reported in Sep 20. The trial met its primary and key secondary endpoints, demonstrating non-inferiority for brolucizumab 6mg vs aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52) [6,7].
Jul 19PIII KINGFISHER trial (NCT03917472) to evaluate efficacy and safety of brolucizumab versus aflibercept plans to recruit 500 patients from the US, Hungary and Slovakia. Estimated primary completion date July 2021 [5].
Mar 19PIII KESTREL and KITE studies are recruiting [3].
Jul 18PIII KITE study to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema starts (NCT03481660). 356 adults will be recruited in countries in the EU and elsewhere. Primary outcome is change from baseline in best-corrected visual acuity (BCVA) at Week 52; collection of these data is due to complete Jul 20 [3].
Jan 18PIII KESTREL study to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular oedema starts (NCT03481634). 534 adults will be recruited from countries including the US & EU (Plus UK). Primary outcome is change from baseline in best-corrected visual acuity (BCVA) at Week 52; collection of these data is due to complete Sep 20 [3].

Evidence based evaluations

BeovuCentral and branch retinal vein occlusion

Information

Beovu
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Suspended
Suspended
Suspended

Category

A humanised monoclonal single chain FV antibody fragment inhibiting vascular endothelial growth factor A (VEGF-A). Given every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment.
Central retinal vein occlusion has an estimated incidence of around 1 in 100,000 per year. The majority of patients are aged >60 years. Younger patients usually have valvular heart disease. Men are slightly more affected than women [1].
Central and branch retinal vein occlusion
Intravitreal

BeovuProliferative diabetic retinopathy

Information

Beovu
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

A humanised monoclonal single chain FV antibody fragment inhibiting vascular endothelial growth factor A (VEGF-A). Given every 6 weeks for a total of 3 injections, followed by 12-weekly maintenance.
DR is a chronic progressive, potentially sight-threatening disease of the retinal microvasculature, associated with the prolonged hyperglycaemia of diabetes mellitus and with other DM-linked conditions, such as hypertension. In T1DM, proliferative retinopathy (formation of new vessels) appears after 10 years and affects ~40% after 20 years. In T2DM, these changes may be found at diagnosis because subclinical hyperglycaemia may have been present for a prolonged period. 83% progress to DR [1].
Proliferative diabetic retinopathy
Intravitreal