预约演示
FDA turns down Outlook's ophthalmic version of Roche's Avastin over manufacturing, data shortfalls
2023-08-30
临床结果临床3期上市批准
The FDA found several problems with Outlook Therapeutics' application for its bevacizumab reformulation despite the drug's positive pivotal trial.
EvenFDAthout an FDA approval, Roche’Outlook Therapeuticsn is widely used by dobevacizumabeat certain eye diseases. Outlook Therapeutics has been trying to get an official approval for a reformulated version, but it instead has received a rejection letter.
The FDA rejectedFDAtlook’s LytRoche, ocancercizumaAvastin for the treatment of wet age-related maculaeye diseasesonOutlook Therapeuticsey company said Wednesday.
The FDAg would have been thLytenavaofficbevacizumab-vikgphthalmic formulation owet age-related macular degeneration (AMD)AMDroval was largely expected by market watchers given existing knowledge and the long history of off-label use of Avastin in eye diseases.
Instead, the FDA found several problems with Outlook’s application despite the pabevacizumabing a positive pivotal trial.Avastineye diseases
In the compleFDAresponse letter to Outlook, the FDA flagged several chemistry, manufacturing and controls (CMC) issues, observations from pre-approval manufacturing inspections, and perhaps most damning, the need for further confirmatory clinical evidence, according to the company.
Outlook will request a meeting with the FDA to fFDAher understand the deficiencies and try to find a path forward, the company’s CEO Russel Trenary said in a statement.
During a Wednesday call with analysts, TFDAary and his team didn’t offer many details about the CRL. The company will have more to share about the agency’s concerns—and a timeline for resolution—after the FDA meeting, the CEO said.
The CMC issues are “addressable” and “manageable,” he added.FDA
Outlook has hired Fujifilm Diosynth Biotechnologies and Ajinomoto Biopharma Services to help make its bevacizumab reformulation. Neither company responded Fierce Pharma’s request for comment by publication time.
Avastin is approveFujifilm Diosynth Biotechnologiescers Ajinomoto Biopharma Servicesvent the growth ofbevacizumabvessels that feed tumors. This anti-VEGF mechanism is also well-accepted in the treatment of diseases featuring abnormal blood vessels in the back of the eye. Regeneron’s Eylea, plus Roche and Novartis’ Lucentis, are blockbuster VEGF inhibitors for the eye.
Meanwhile, severaFDAvastin biosimilars are available in the U.S. But these copycatsbevacizumabfficially go after the same indications as the originator.
Twelve years ago, aAvastinoration between the University of Pennsylvania and the National Eye Institute found that Avastin and Lucentis had equivalent effects on improving visual acuity in wet AMD. But those results were never used for an FDA application.
In Outlook’s phase 3 NORSE TWO trial, 42% of wUniversity of Pennsylvaniaytenava, National Eye Institute, gained at Avastin5 letLucentisree lines) of vision in a common test. The trial met iwet AMDAMDary and secondary endpoints with high statiFDAcal significance, Trenary stressed.
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