Biologics

Enzyvant Resubmits BLA for Pediatric Congenital Athymia

Enzyvant has resubmitted a BLA for RVT-802 (cultured human thymus tissue), a tissue-based regenerative therapy designed to treat pediatric congenital athymia, a rare and deadly condition associated with complete DiGeorge anomaly, Charge syndrome, and FoxN1 deficiency, according to the company. The submission addresses a 12/2019 Complete Response Letter and FDA requests related to chemistry, manufacturing and controls information. The agency set a review action target date of 10/8.

Children with congenital athymia are born without a thymus, resulting in a severe immunodeficiency due to the inability to produce normally functioning T cells, which defend against infection and regulate essential processes in the immune system, Enzyvant says. RVT-802 works, it says, by stimulating the body’s production of naive, immunocompetent T cells, with the goal of bolstering the immune system and restoring the body’s ability to fight infection.

RVT-802 is derived from infant thymus tissue, and it is processed and cultured prior to implantation into a patient’s quadricep muscle, the company says “The patient’s bone marrow stem cells migrate to the implanted tissue product, where they are trained to become naïve, immunocompetent T cells,” it says. “With the renewed ability to generate T cells, immune system function can be restored.”

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