Articles related to FDA

Anakinra (Kineret, Sobi) currently approved for rheumatoid arthritis and some rare disorders, was granted an emergency use authorization for a subgroup of COVID-hospitalized patients who are at risk of severe respiratory failure.

This approval was based on findings from the open-label, randomized, multicenter POSEIDON trial, which compared data from two of the study’s three treatment arms. When compared to patients in the other treatment arm, patients in this group had a significantly improved OS, with a median OS of 14 months as opposed to 11.7 months.

Artri King and other products with a similar name were the subject of an FDA analysis that exposed hidden drug ingredients, including corticosteroids (diclofenac and dexamethasone). The FDA sent warning letters to Amazon, Walmart, and Latin Foods Market on October 28, 2022, for distributing various Artri and/or Ortiga unapproved and misbranded drug products. Some of these products may still be available on the market. These products have already been voluntarily recalled by Walmart and Latin Foods Market.

Basimglurant is a highly selective, potent, and cell-penetrant negative allosteric modulator of metabotropic glutamate receptor 5 (mGluR5). Based on the LibraTN trial — a 24-week, prospective, double-blind, randomized-withdrawal, placebo-controlled study of basimglurant for trigeminal neuralgia, FDA has granted the molecule Fast Track designation.

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously decided on October 28 that there is insufficient evidence to support the claim that the pediatric oncology drug 131-I-omburtamab improves overall survival. A radiolabeled antibody, 131-I-omburtamab was created to treat central nervous system/leptomeningeal (CNS/LM) metastases in pediatric patients with neuroblastoma.

The FOENIX*-CCA2 trial, a global phase 2, open-label trial examining 103 patients with unresectable, locally progressed, or metastatic iCCA harboring FGFR2 gene rearrangements including fusions, was the basis for the approval of futibatinib (Lytgobi, Taiho Oncology). Patients in this trial received 20 mg of futibatinib orally once daily until disease progression or intolerable toxicity; the primary end goal was achieved with a 42% objective response rate as determined by an impartial central evaluation. With 72% of responses lasting at least six months, the median response time was 9.7 months.