Outlook Therapeutics, Inc. · eksiksiz yanıt mektubu (CRL) (BLA 761320)

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( Lg my U.S. FOOD & DRUG Ny, ADMINISTRATION BLA 761320 COMPLETE RESPONSE Outlook Therapeutics, Inc. Attention: Jennifer Kissner, PhD Executive Vice President 111 South Wood Avenue Unit #100 Iselin, NJ 08830 Dear Dr. Kissner: Please refer to your biologics license application (BLA) dated and received for bevacizumab-vikg injection. We acknowledge receipt of your amendment dated Lb) a complete response to our Oe) , action letter. , which constituted We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues. There is a lack of substantial evidence consisting of adequate and well-controlled investigations, as defined in § 314.126, that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling. NORSE TWO met its primary endpoint for effectiveness. In NORSE EIGHT, » (bevacizumab-vikg) injection did not meet the primary efficacy endpoint of mean change from baseline in ETDRS BCVA score at the Week 8 visit in comparison to ranibizumab using a non-inferiority margin of -3.5 letters. The submitted additional mechanistic and natural history data information does not alter the review conclusion that while one adequate and well controlled study demonstrating efficacy has

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