American company Perspectives on Therapy trying to get approved Litenavaa reformulated version of Roche’s cancer drug, but was ultimately rejected by the United States Food and Drug Administration (USA).FDAabbreviation in English).
Litenava, also known as bevacizumab-vikg, is for the treatment of age-related macular degeneration (AMD). If approved, the drug would be the first ophthalmic composition officially marked for market entry.
Executive Director Russell Trenari said they will request a meeting with the FDA to better understand the shortcomings of their project and try to find a new path to achieve the long-awaited approval.
According to Fierce Pharma, analysts were betting that Litenava would get the green light, given the knowledge available and the drug’s long history of unauthorized use. Avastin for eye diseases. However, the FDA has identified several issues with the proposed Outlook application related to chemistry, manufacturing, and safety controls, as well as the need for additional supporting clinical data.
On behalf of the company, in particular its executive director, Russell Trainarysaid they would request a meeting with the FDA to better understand the shortcomings of their project and try to find a new path to achieve the long-awaited approval.
Twelve years ago, a collaboration between the University of Pennsylvania and the National Eye Institute revealed that Avastin and Lucentis equivalent effects in improving visual acuity in AMD. Despite this, these results were never used in the FDA application.
On the other hand, the Phase 3 NORSE TWO Outlook study demonstrated that 42% of AMD patients who took Lytenava, also under the code ONS-5010, received at least 15 letters (three lines) of vision in a conventional test. Trenari noted that the study reached primary and secondary endpoints with high statistical significance.