FDA Roundup: Myhibbin for Prophylaxis of Organ Rejection, Insulin App Recall

FDA Approves Myhibbin for Prophylaxis of Organ Rejection in Adult, Pediatric Transplant Recipients

The FDA approved mycophenolate mofetil oral suspension (Myhibbin), an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in both adults and pediatric recipients (aged 3 months and older) of allogenic kidney, heart, or liver transplants, in combination with other immunosuppressant therapies.

A number of clinical trials contributed to FDA approval. For kidney transplants, 3 de novo studies compared 2 dose levels of oral mycophenolate mofetil (1 g and 1.5 g, both twice daily) with azathioprine or placebo (2 studies and 1 study, respectively) to prevent acute rejection episodes. The primary efficacy endpoint across all 3 studies was the proportion of patients in each treatment group who experienced treatment failure within the first 6 months following transplantation.

Mycophenolate mofetil oral suspension contains a boxed warning for embryofetal toxicity, malignancies, and serious infections. The use of this medication during pregnancy is associated with increased risks of pregnancy loss and congenital malformations; it should be avoided if safer treatment options are available. The drug has also been associated with an increased risk in the development of lymphoma and other skin malignancies.

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Insulin App Recall Prompts FDA Warning After More Than 200 Reported Injuries

Tandem Diabetes Care, Inc, a medical device manufacturer, has issued a voluntary recall of a mobile insulin management app due to a software malfunction. The glitch has led to more than 200 confirmed injuries and leaves thousands at risk of further harm.

Tandem Diabetes Care recalled version 2.7 of the Apple iOS t:connect mobile app, a companion app for the company’s t:slim X2 insulin pump with Control-IQ technology. The FDA identified the recall as Class I—the most serious type of recall—and warned users that the app malfunction could cause serious injuries or death.

The reason for the recall is a software malfunction that can cause the device to repeatedly crash and restart. This loop drains the insulin pump’s batter faster than usual, which could lead to the pump shutting down unexpectedly. Unexpected pump shutdowns cause interruptions in insulin delivery, putting users as risk of hyperglycemia or diabetic ketoacidosis, due to dysregulation.

FDA Delays Decision on Moderna’s RSV Vaccine

The FDA delayed its decision on Moderna’s investigational respiratory syncytial virus (RSV) vaccine due to administrative constraints. The federal agency said that it expects to complete a review of the Biologics License Application (BLA) for mRNA-1345 by the end of May, instead of the original Prescription Drug User Fee Act (PDUFA) date of May 12.

Moderna said that the FDA did not inform it “of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345.” The vaccine is still set to be reviewed at a meeting with the CDC’s Advisory Committee on Immunization Practices (ACIP) that is being held June 26 to 27.

A rolling BLA submission was supported by data from the ConquerRSV study (NCT05127434), a phase 2-3 trial evaluating the safety and tolerability of mRNA-1345, as well as the efficacy of a single dose to prevent a first episode of RSV-associated lower respiratory tract disease. Findings from the study showed that, over a median follow up of 112 days, the vaccine had an efficacy of 83.7% against RSV-associated lower respiratory tract disease with at least 2 signs or symptoms and 82.4% with at least 3 signs or symptoms.

FDA Advisory Committee Will Soon Meet to Discuss MDMA-Assisted Therapy for PTSD

The FDA’s Psychopharmacologic Drugs Advisory Committee will meet on June 4 to review a new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD).The committee meeting will be the first to review a psychedelic-assisted therapy in the United States, as well as the first in 25 years to review a potential new PTSD treatment.

Since the Controlled Substances Act was passed in 1970 and federal drug schedules were made, most psychedelic substances were placed into Schedule I and were deemed to have no medical benefit. Not only would MDMA’s approval represent a historic shift in psychedelic medicine, but it could also “open the door to a potentially powerful new pathway to healing” for patients with PTSD, according to Bessel van der Kolk, MD.

"This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy," Amy Emerson, CEO of Lykos Therapeutics, said in a release. "We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD."

FDA Approves IND for mRNA Vaccine for Epstein-Barr Virus-Related Cancer

The FDA approved the investigational New Drug (IND) application for WGc-043, the first and only Epstein-Barr virus-related mRNA cancer vaccine. The vaccine has demonstrated positive efficacy, low toxicity, and broad applicability; it has also been shown to be cost effective. Investigator-initiated trials of the WGc-043 vaccine in nasopharyngeal cancer and natural killer T-cell lymphoma showed “superior safety and efficacy compared to other publicly available mRNA therapeutic cancer vaccines.”

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