Drugs

‘Complete Response’ on Stem Cell Transplant Therapy

FDA has issued Omeros a complete response letter on its BLA for narsoplimab as a treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In the letter, according to the company, FDA said it had difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA 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.

The BLA was accepted for filing in January and given priority review status. In May, FDA extended the user fee target action date by three months (to 10/17) in response to an agency information request that was classified as a major amendment requiring additional time to review. The BLA was accepted for filing in January and given priority review status.

HSCT-TMA is a significant and often lethal complication of stem cell transplantation. “This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation,” the company says. “Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA,” it says.

Omeros plans to request a Type A meeting with FDA soon to discuss the letter determine the path forward for approval of narsoplimab in the treatment of HSCT-TMA.

Narsoplimab is designed to target mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement.

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