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2023
Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following retinal vein occlusion. The clinical trials demonstrated non inferiority against aflibercept (marketed by Bayer/Regeneron’s as Eylea®). The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023, which is its third approved indication.
Vabysmo® was first FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022. Vabysmo® was first FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.
Roche has announced that it has successfully concluded meetings with pan-Canadian Pharmaceutical Alliance (pCPA) regarding Vabysmo® (faricimab). The company said that it secured a letter of intent with the pCPA for Vabysmo®, a treatment indicated for neovascular age-related macular degeneration and diabetic macular edema. The pCPA’s mandate is to enhance patient access to clinically relevant and cost-effective drug treatment options by conducting collective, expert-informed negotiations for drugs.
Roche Canada intends to work with other provincial jurisdictions to make Vabysmo® available as soon as possible through public drug plans.
This news comes a few weeks after the FDA accepted Roche’s sBLA for Vabysmo® to treat macular edema following retinal vein occlusion.
Roche announced that the FDA has accepted its sBLA for Vabysmo® (faricimab) to treat macular edema following retinal vein occlusion. The sBLA is based on results from the phase III BALATON and COMINO studies which met primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.
Last year, Health Canada approved Vabysmo® for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.
2022
Roche announced that Health Canada has approved Vabysmo® (faricimab) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). This is the first approved treatment in Canada for wet AMD and DME that targets both VEGF-A and Ang-2.
The UK’s NICE published final draft guidance recommending Vabysmo® (faricimab) for the treatment of adult patients with wet age-related macular degeneration (AMD) or diabetic macular oedema (DMO).
Genentech announced that the FDA has approved Vabysmo™ (faricimab) for the treatment of people with wet age-related macular degeneration and diabetic macular edema.
2021
Roche announced new Ph III data shows faricimab (given at intervals of up to four months) is non-inferior compared to aflibercept (given every two months). This may reduce the treatment burden for patients suffering from diabetic macular edema and neovascular age-related macular degeneration.
2020
Roche announces results for its investigational bispecific antibody faricimab in patients with diabetic macular edema. Roche announced that the candidate was generally well-tolerated with no new safety signals identified. This product is being developed as a replacement for Lucentis® (ranibizumab), which lost patent protection in the US this year.
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
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