Biologics

Mesoblast Refiling BLA for Remestemcel-L

Mesoblast says it will refile next quarter its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease (SR-aGVHD) following favorable guidance from FDA regarding the company’s clinical data. On 8/4/2023, the agency issued a second complete response letter that requested more data to support marketing approval. The company now says that recent input from the agency found the available clinical data from the company’s Phase 3 study MSB-GVHD001 appears to be sufficient to support resubmission.

In 2020, FDA issued a complete response letter on the original BLA and recommended that the company conduct at least one additional randomized, controlled study in adults or children to provide further evidence of the therapy’s effectiveness. Additionally, FDA identified a need for further scientific rationale to “demonstrate the relationship of potency measurements to the product’s biologic activity,” the company said at the time. “Assays measuring the potency of remestemcel-L will continue to be refined to provide further scientific rationale for its use in severe inflammatory diseases with high mortality risk,” it said.

Prior to the latest complete response action, FDA’s Oncologic Drugs Advisory Committee voted nine to one in favor of approving the therapy. The positive vote negated FDA briefing documents that challenged the biologic’s effectiveness and durability of patient responses (see earlier story).

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