Drugs

CRL for Outlook’s Wet AMD Drug

FDA has issued a complete response letter to the Outlook Therapeutics BLA for ONS-5010/Lytenava (bevacizumab-vikg), indicating that the agency wants to see more confirmatory evidence for the drug as a treatment for wet age-related macular degeneration (wet AMD). A company statement says FDA noted in its letter that the additional mechanistic and natural history data provided in the BLA resubmission did not alter the previous review conclusion that while the one study demonstrated efficacy, FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application. Outlook says FDA did not specify the type of confirmatory evidence it would accept.

Company officials said they were disappointed by and disagreed with the agency's decision and remain committed to taking all necessary steps to receive FDA approval.

Outlook says the BLA resubmission was based on the complete data set from the NORSE clinical trial program, including the successful NORSE TWO pivotal trial as well as confirmatory safety and efficacy data from all other NORSE trials, including the NORSE EIGHT non-inferiority study. “Outlook Therapeutics continues to believe that the complete data set for NORSE TWO combined with the data from the other NORSE clinical trials provides the required evidence to support approval of the ONS-5010 BLA in the U.S.,” the statement says.

Lytenava is described as a recombinant humanized monoclonal antibody that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors, Flt-1 and KDR, on the surface of endothelial cells.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome