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LoA Update: Roche’s faricimab FDA approval chances in wet AMD rises by 7 points due to positive Phase III data

By Sean Rai-Roche 19 Feb 2021 (Last Updated March 18th, 2021 09:17)

As on 15 February, the FDA likelihood of approval (LoA) for Roche’s (SIX:ROG) faricimab in neovascular age-related macular degeneration (wet AMD) went up 7 points, according to GlobalData’s LoA data.

LoA Update: Roche’s faricimab FDA approval chances in wet AMD rises by 7 points due to positive Phase III data
The update is due to Roche’s Phase III TENAYA trial (NCT03823287) reporting noninferior vision gains to a rival at double the dosing interval. Credit: Roche

As on 15 February, the FDA likelihood of approval (LoA) for Roche’s (SIX:ROG) faricimab in neovascular age-related macular degeneration (wet AMD) went up 7 points, according to GlobalData’s LoA data. The update is due to Roche’s Phase III TENAYA trial (NCT03823287) reporting noninferior vision gains to a rival at double the dosing interval.

While faricimab previously had a 36% LoA, this increased to 43% after the results using GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. According to a 12 February media release, faricimab delivered noninferior visual improvement to Regeneron Pharmaceuticals’ (NASDAQ:REGN) Eylea (aflibercept). While Eylea is administered every two months, faricimab can be given in intervals up to four months, according to the same data release. Around half of people who qualified for extended dosing with faricimab could be treated every four months in the first year in the TENAYA and accompanying Phase III LUCERNE (NCT03823300) study for wet AMD, said the release. The studies evaluated faricimab administered at intervals of every two, three or four months, in contrast to Eylea given every two.

On 17 December 2019, this news service reported that TENAYA and LUCERNE were powered for noninferiority versus Eylea. In addition, experts explained how Roche performed a 76-patient Phase II wet AMD trial called STAIRWAY (NCT03038880), which was powered to explore durability. It found that roughly 65% of patients could be extended to a treatment of once every four months. Roche has a market cap of USD 267.81bn (18 February).

Sean Rai-Roche is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.