The ID Pipeline: FDA Activity From the Week of November 3, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of November 3, 2019.

FDA Authorizes Marketing of an HIV-1 Drug Resistance Test

On Tuesday, November 5, 2019, the FDA authorized marketing of the Sentosa SQ HIV Genotyping Assay, a test that detects HIV-1 drug resistance mutations using next-generation sequencing technology. The assay is the first HIV drug resistance test using next-generation sequencing technology to be authorized for marketing in the United States. The FDA granted the marketing authorization to Vela Diagnostics USA Inc.

The Sentosa SQ HIV-1 Genotyping Assay detects drug resistance mutations in patients who are undergoing or about to undergo antiviral therapy. The assay detects mutations in the genetics of HIV in a sample of blood using next-generation sequencing.

The FDA examined data from performance studies demonstrating a greater than 95% sensitivity and specificity in detecting 342 drug resistance mutations. This led to the conclusion that the assay provides reasonable assurance of safety and effectiveness for its intended use.

Read the full article here.

FDA Approves Fluzone High-Dose Quadrivalent Influenza Vaccine for Older Adults

On Monday, November 4, 2019, the FDA approved Sanofi’s Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. The vaccine will be made available for the 2020-2021 influenza season.

The approval of the supplemental Biologics License Application marks a transition from the company’s trivalent influenza vaccine first approved in 2009 that contained 2 influenza A strains and 1 influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain.

In a phase 3 immunogenicity and safety trial, the quadrivalent vaccine met its primary end point of non-inferior immunogenicity compared with 2 trivalent formulations of Fluzone High-Dose. Additionally, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared with the trivalent formulation.

Read the full article here.

FDA Approves RHB-105 to Treat H Pylori

On Monday, November 4, 2019, RedHill Biopharma Ltd announced that the FDA approved RHB-105 (Talicia) for the treatment of Helicobacter pylori in adults.

H pylori affects approximately 35% of the United States adult population and is classified as a group 1 carcinogen. It is the strongest risk factor for the development of peptic ulcer disease, gastritis, and non-cardia gastric cancer.

Talicia is a 3-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, and is a novel, fixed-dose, all-in-one delayed-release capsule 10 mg/250 mg/12.5 mg.

The approval was granted based on the results of 2 phase 3 studies in adults with H pylori, who suffered epigastric pain or discomfort. The confirmatory phase 3 study demonstrated 84% eradication of H pylori in participants treated with Talicia, compared to 58% in the active competitor arm (p<0. .0001).

Read the full article here.