On December 18, the official website of the State Food and Drug Administration (NMPA) of China announced that the faricimab injection declared by Roche has been officially approved.
According to the Yakudu data retrieval, faricimab is the world's first ophthalmic drug targeting VEGFA angpt2 bispecific antibody developed by Roche, which was first approved by the FDA in January 2022 and approved for marketing in Japan and Europe in the same year. Currently approved indications include: **Wet age-related macular degeneration (AMD) and diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO).
Mechanism of action
Faricimab targets both vascular endothelial growth factor A (VEGF-A) and angipoietin-2 (ANG-2), which can enhance vascular leakage and inflammation and increase vascular sensitivity to VEGF-A activity, leading to further vascular instability. Ang-2 and VEGF-A synergistically increase vascular permeability and stimulate new vascularization, and through the dual inhibition of ANG-2 and VEGF-A, faricimab can reduce vascular permeability and inflammation, inhibit pathological angiogenesis and restore vascular stability.
At this year's Annual Meeting of the Association for the Study of Vision and Ophthalmology (ARVO), Roche presented the results of a one-year study of the Rhine study of farecimab**DME (NCT03622593) in a subgroup of Chinese populations.
The data showed that the dosing interval of 12 weeks or more could be achieved in 75% of patients in the individualized frecimab** group, and 16 weeks in 50% of patients. The overall safety and tolerability data for faricimab were consistent with the global data, and the Chinese subset results showed consistency with the global population on the primary endpoint.
Sales
Since its launch, fareximab has been performing well in terms of sales, with global sales reaching 6$5.5 billion (5.5 billion)CHF 9.1 billion), with total sales of CHF 17 in the first three quarters of 2023$8.8 billion (16..)CHF 1.3 billion), sales are expected to exceed USD 2 billion this year.
References
1) The official website of the National Medical Products Administration (NMPA) of China.
2) Yaodu database.
3）aflibercept versus faricimab in the treatment of neovascular age-related macular degeneration and diabetic macular edema: a review
4) Roche Pharmaceutical's official website.
*: Yakudo daily
Original: Jiang Li.
Yaodu official website: Yaodu-Global Pharmaceutical Big Data CIO Service Platform (Pharmacodia.).com)