[{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Approves Safety Label Update for Novartis Beovu\u00ae","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Reports Positive Topline Results from the First Phase III Trial of Beovu\u00ae Vs Aflibercept in Patients with Diabetic Macular Edema","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large 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Applicable","newsHeadline":"Novartis Reports One Year Results of Phase III MERLIN Study Evaluating BEOVU\u00ae Every Four Week Dosing and Provides Update on BEOVU Program","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Stops Three Late-Stage Studies of Beovu Eye Drug Citing Patient Safety","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Announces Positive Results from Phase III Trials of Beovu\u00ae in Diabetic Macular Edema, Including Dosing Intervals up To 16 Weeks","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Announces FDA and EMA Filing Acceptances of Beovu\u00ae for Patients with Diabetic Macular Edema","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"October 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Find Clinical Drug Pipeline Developments & Deals for Brolucizumab
Under the agreement, Vector will distribute Pepaxti (melphalan flufenamide), indicated in combination with dexamethasone, in the MENA region for the treatment of patients with multiple myeloma.
Patients treated with BEOVU (brolucizumab) in KESTREL and KITE demonstrated a significant reduction from baseline in central subfield thickness (CST) starting at week four and continuing up to week 52.
Beovu (brolucizumab, also known as RTH258) 6 mg is approved for the treatment of wet age-related macular degeneration (AMD) in more than 70 countries, including in the US, EU, UK, Japan, Canada and Australia.
Beovu® (brolucizumab) is approved for the treatment of wet age-related macular degeneration (AMD) currently being developed for diabetic macular edema (DME).
KESTREL, KITE and KINGFISHER are global, randomized, double-masked, Phase III, two-year studies comparing the safety and efficacy of Beovu and aflibercept in the treatment of DME.
The three trials were all testing an experimental once-monthly dosing regimen for Beovu, which is already approved for wet AMD as an injection into the eye every two or three months.
Beovu met MERLIN’s primary endpoint of non-inferiority in change in best corrected visual acuity from baseline and superiority on select anatomical secondary endpoints at year one versus aflibercept.
In Phase III KESTREL study, Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52).
Analyses of US real-world and Phase III data presented at the American Academy of Ophthalmology (AAO) 2020 Meeting reported baseline patient characteristics potentially linked with incidence of inflammation-related adverse events that may occur following treatment with Beovu.
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