US Advisory Committees

The injection for radicular leg pain appears likely to be approved, but with a very prescriptive label to help balance safety concerns and a lack of long-term outcomes data.

An FDA advisory committee will consider modifications to the indicated patient population, as well as the appropriate health professionals and settings to administer the proposed treatment for radicular leg pain.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

The development of a joint document is not iterative and there is no discussion between the agency and sponsor, according to new guidance seemingly aimed at differentiating the frequent use of joint backgrounders in oncology from the single document developed for the Alzheimer's drug Aduhelm.

A safety signal may be platform or even Moderna-specific, the Vaccines and Related Biological Products Advisory Committee said.

The FDA wants to update 2017 requirements for the data needed before initiating RSV vaccine trials in infants and toddlers after vaccine-associated enhanced respiratory disease triggered an indication-wide research hold.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

The FDA and sponsors should have surveyed providers and patients who do not prescribe or use the antipsychotic clozapine to find whether the REMS restrictions were hindering access and causing harm, advisory committee members and patient advocates said.

The agency reaffirmed support for a hemoglobin A1C endpoint for glycemic control in type 1 diabetes, but the diabetic ketoacidosis risk with sotagliflozin is so concerning that it is looking for additional benefits in patients with chronic kidney disease, a targeted subpopulation.

The Cellular, Tissue and Gene Therapies Advisory Committee appeared unsatisfied with the risk-benefit balance of the anticoagulant reversal agent in the confirmatory trial, but was not ready to throw out the product, suggesting new trials may be needed.

The atypical antipsychotic’s Risk Evaluation and Mitigation Strategy should be retired because the requirements for prescriber education and documentation on absolute neutrophil count monitoring are hindering access, panelists said.

The confirmatory trial for the anticoagulant reversal agent raised safety and efficacy concerns from the agency.

The antipsychotic’s Risk Evaluation and Mitigation Strategy has never been fully implemented or enforced due to operational and technical challenges. The FDA now is re-evaluating the need for the program given changes in the health care landscape and medical training since the drug’s 1989 approval.

GSK’s Arexvy and Pfizer’s Abrysvo are FDA-approved for individuals younger than 60 years old, but CDC’s Advisory Committee on Immunization Practices wants more data on Guillain-Barré syndrome cases in older adults and efficacy in severely immune-compromised persons before making a recommendation.

Some panelists favored use in T1D patients with mild chronic kidney disease, even though that was not the original indication Lexicon proposed, which was rejected in an 11-3 vote.

The Pharmacy Compounding Advisory Committee unanimously voted to add hydroxyprogesterone caproate products for reducing the risk of recurrent singleton spontaneous preterm birth to the Withdrawn or Removed List under sections 503A and 503B of the Food, Drug and Cosmetic Act.

The Zynquista application in type 1 diabetes received a complete response letter in 2019. This time, Lexicon seeks approval for patients with T1D and chronic kidney disease. FDA review staff said making definitive conclusions about the magnitude of glucose-lowering effects in this population is difficult, and the risk of diabetic ketoacidosis remains.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

The US CDC committee appears on track to recommend GSK’s five-in-one vaccine when use of both a quadrivalent vaccine and a separate meningitis B vaccine are indicated at the same visit, the approach adopted for Pfizer’s Penbraya.

Advisory Committee on Immunization Practices wants to shift from a risk-based to an age-based recommendation for PCV-naïve adults between the ages of 50 and 64. The recommendation would put Merck’s recently approved Capvaxive and Pfizer’s market-leading Prevnar 20 on equal footing.