Drugs

FDA OKs 1st Diabetes Cellular Therapy

FDA has approved CellTrans’ Lantidra (donislecel), the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells to treat Type 1 diabetes. An agency announcement says Lantidra is approved to treat adults with Type 1 diabetes who are unable to approach targeted glycated hemoglobin due to current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.

Lantidra’s primary mechanism of action, the statement says, is believed to be the secretion of insulin by the infused allogeneic islet beta cells. Its safety and effectiveness were evaluated in two single-arm studies with 30 participants. Overall, FDA says, 21 participants did not need insulin for one to five years and 10 participants did not need insulin for more than five years. Five participants did not achieve any days of insulin independence.

Adverse reactions associated with Lantidra reportedly were associated with each participant depending on the number of infusions they received and the length of time they were followed. The most common adverse reactions included nausea, fatigue, anemia, diarrhea, and abdominal pain. A majority of participants experienced at least one serious adverse reaction related to the procedure for infusing Lantidra into the hepatic portal vein and the use of immunosuppressive medications needed to maintain the islet cell viability, FDA says.

Lantidra is approved with patient-directed labeling to inform patients about its benefits and risks.

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