Roche Seeks EU Marketing Approval For Novel Eye Disease Drug Faricimab

If approved, Roche’s bispecific antibody could become the first in a new class of medicines in years for treating macular degeneration and diabetic macular edema.

Source: Alamy

Roche has filed its new eye disease drug for regulatory review in the EU

Faricimab, Roche’s investigational bispecific antibody for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), has now been filed with the European Medicines Agency for review for potential pan-EU marketing authorization.

If approved, faricimab could become the first in a new class of medicine in 15 years for nAMD and in close to a decade for DME, according to Roche. A marketing application for the product was also recently submitted for review in Japan. 

Faricimab is among a number of new products that the EMA added to its latest monthly list of products under review for potential marketing approval. The list was published on 9 July and comprises data extracted on 6 July. (Also see "Orphan Drugs Nefecon, Maribavir & Copanlisib Among New EU Filings" - Pink Sheet, 19 Jul, 2021.)

As noted by Roche, faricimab is the first investigational bispecific antibody designed for the eye.

In addition, it is one of two potential first-of-a-kind treatments for retinal diseases that are in the company’s late-stage product pipeline. The other is the Port Delivery System with ranibizumab (PSD), the marketing authorization application (MAA) for which was filed with the EMA in June, for treating nAMD. A marketing application for the PDS has also been submitted in the US, with approval by the Food and Drug Administration anticipated by late 2021. (Also see "Roche’s Novel Ranibizumab Implant Among Myriad New Filings In EU" - Pink Sheet, 11 Jun, 2021.)

Regarding the Japanese filing for faricimab, in June Roche’s member company Chugai Pharmaceutical said it had filed a marketing application for review by the Ministry of Health, Labour and Welfare.

In February, Roche announced positive Phase III clinical data that showed faricimab was the first investigational injectable eye medicine to extend time between treatments up to four months for nAMD and DME, potentially reducing treatment burden for patients.

Faricimab works by simultaneously blocking two distinct pathways – angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditions. In doing so, it is designed to stabilize blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions.