Test for Opioid Addiction; Filsuvez for Epidermolysis Bullosa; Budesonide for IgAN; Eplontersen for hATTR-PN; NRX-101 for complicated UTI; Gefapixant for Chronic Cough; V116 for Invasive Pneumococcal Disease; Sotorasib in NSCLC

New FDA Approvals

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Here are the highlights:

Test for Risk of Opioid Addiction:The FDA has approved AvertD by SOLVD Health, a test for assessing opioid addiction risk in individuals over 18, using genetic variants to evaluate addiction risk before prescribing oral opioids for acute pain; however, it's met with skepticism and not intended for chronic pain patients.

https://www.cnn.com/2023/12/20/health/opioid-use-disorder-test-avertd/index.html

https://avertdtest.com/

Filsuvez for Junctional Epidermolysis Bullosa:Filsuvez, a birch triterpenes topical gel, received FDA approval for treating Junctional and Dystrophic Epidermolysis Bullosa (JEB/DEB) in individuals aged 6 months and older, marking the first FDA-approved therapy for JEB's partial thickness wounds and a significant advancement in managing this debilitating skin disorder.https://resources.chiesiusa.com/Filsuvez/FILSUVEZ_PI.pdf

Budesonide for IgA Nephropathy:Budesonide (Tarpeyo) received full FDA approval for reducing kidney function loss in adults with IgA nephropathy (IgAN), targeting specific antibodies implicated in IgAN based on phase 3 NefIgArd clinical trial data, marking the first FDA approval for IgAN treatment based on kidney function measures.

https://www.tarpeyo.com/prescribinginformation.pdf

Eplontersen for hATTR Polyneuropathy:Eplontersen (Wainua) was approved by the FDA for treating polyneuropathy in adults with hereditary transthyretin-mediated amyloidosis (hATTR-PN), based on the NEURO-TTRansform Phase III trial, and is the only hATTR-PN treatment that can be self-administered via an auto-injector.

https://pubmed.ncbi.nlm.nih.gov/37768671/ https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217388s000lbl.pdf

NRX-101 for Complicated UTI:The FDA cleared an Investigational New Drug application for NRX-101, a D-cycloserine and lurasidone blend developed by NRx Pharmaceuticals for treating complicated urinary tract infections, with a pending request for Qualified Infectious Disease Product designation.

https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-fda-clearance-of-its-investigational-new-drug-ind-application-for-nrx-101-in-the-treatment-of-complicated-urinary-tract-infections-302017523.html?utm_source=pocket_saves

Gefapixant for Chronic Cough:Merck's gefapixant, a selective antagonist of P2X3 receptors for treating chronic cough, was rejected by the FDA for the second time due to insufficient evidence of effectiveness in treating refractory or unexplained chronic cough in adults.

https://www.businesswire.com/news/home/20231220302305/en/Merck-Provides-U.S.-Regulatory-Update-on-Gefapixant

V116 for Invasive Pneumococcal Disease:Merck's V116, a 21-valent pneumococcal conjugate vaccine, was accepted by the FDA for priority review to prevent invasive pneumococcal disease in adults, based on STRIDE-3 Phase 3 trial data, with a target action date set for June 17, 2024.

https://www.merck.com/news/fda-grants-priority-review-to-mercks-new-biologics-license-application-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults

Sotorasib in NSCLC:Lumakras (sotorasib), already under accelerated approval for KRASG12C-mutated non-small cell lung cancer (NSCLC), faces uncertainty for full FDA approval after an advisory committee voted against it, though it will remain available for clinical use.https://www.onclive.com/view/codebreak-200-sotorasib-in-second-line-kras-g12c-mutated-nsclc

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