Drugs

Omeros Loses Appeal on Stem Cell Transplant Drug

CDER’s Office of New Drugs (OND) has denied an Omeros appeal of a complete response letter (CRL) on its BLA for narsoplimab as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy. In the CRL, according to the company, FDA said it had difficulty in estimating the drug’s treatment effect and requested additional information to support approval. It also said there were no chemistry, manufacturing and controls, safety, or non-clinical issues standing in the way of approval. Narsoplimab is designed to target mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway of complement.

Under the formal dispute resolution request, Omeros asked OND to direct the review division to accept a resubmission of the existing BLA and to begin labeling discussions with the company immediately thereafter. “Although that request was denied, the decision proposes a path forward for the resubmission of the BLA based on survival data from the completed pivotal trial versus an historical control group,” the company says. “Specifically, the decision proposes the resubmission of the narsoplimab BLA including a comparison of the existing response data from the completed pivotal trial to a threshold derived from an independent literature analysis and evidence of increased survival from patients in the pivotal trial compared to an appropriate historical control group. It also notes that persuasive evidence of superior survival versus a well-matched historical control group could be sufficient even in the absence of the independent literature analysis.”

Omeros says it is currently working through the details of the appeal decision and potential next steps with its regulatory and legal advisors.

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