Biologics

FDA to Review Inovio BLA to Treat RRP

FDA has set a PDUFA action date of 10/30 for its review of an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis (RRP). A company statement says the BLA was filed under the Accelerated Approval pathway.

Inovio says the agency acceptance letter raised a preliminary conclusion that the company had not submitted adequate information to justify eligibility for an accelerated approval. “Inovio continues to believe that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval,” the statement says. Inovio says it plans to request a meeting with FDA officials to discuss next steps to remain eligible for the accelerated approval pathway.

The company says the BLA is supported by data from a Phase 1/2 trial that evaluated the treatment in adults with RRP who had two or more surgeries in the year before treatment.

INO-3107 is described as an investigational DNA medicine designed to elicit an antigen-specific T-cell response against both HPV-6 and HPV-11 proteins. The targeted T-cells are said to seek and kill HPV-6 and HPV-11 infected cells with the aim of potentially preventing or slowing the growth of new papillomas. It says that in a Phase 1/2 trial with 32 participants, 72% of patients saw a 50% to 100% reduction in the number of surgeries after starting treatment with INO-3107 at the end of the first year.

FDA has granted the drug both Orphan Drug and Breakthrough Therapy designations.

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