This week’s report includes the latest on Gilead’s new drug application (NDA) for their fixed-dose combination treatment, results of Janssen’s Phase 2b Trial for pimodivir, access to data presented at ASM Microbe 2017 from Spero Therapeutics on their new antibiotics, new product enhancements released by Clorox, and news that TECHLAB has received FDA 510(K) clearance to market their E. HISTOLYTICA QUIK CHEK™
Gilead Submits New Drug Application Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment
Gilead Sciences, Inc. (NASDAQ: GILD) announced this week
that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.
Pimodivir Shown to Decrease Viral Load in Adult Patients with Seasonal Influenza A in Phase 2b Trial
Janssen Pharmaceuticals, Inc. (Janssen) announced results
from the Phase 2b Topaz Trial which demonstrated that treatment with pimodivir (JNJ-63623872) significantly decreased viral load over seven days versus placebo, in adult patients with acute, uncomplicated seasonal influenza A. Patients treated with pimodivir and oseltamivir (OST) also demonstrated a significantly lower viral load compared with those who received pimodivir alone at the same dose. The primary endpoint data for the trial, presented in an oral presentation at the 5th
International Society for Influenza and Respiratory Diseases Antiviral Group (ISIRV-AVG) Conference in Shanghai, China, showed treatment with pimodivir resulted in a statistically significant decrease in area under the curve (AUC) of viral load (by quantitative real-time-polymerase chain reaction [qRT-PCR]) over seven days from start of dosing, compared with placebo. Pimodivir received U.S. FDA Fast Track designation in March 2017 due to its potential to address an unmet medical need in those who develop influenza A infection and who are hospitalized or at high risk of related complications. Phase 3 studies are anticipated to start in the second half of 2017.