The ID Pipeline: FDA Activity From the Week of September 1, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of September 1, 2019.

FDA Approves Labeling Changes for Sovaldi and Harvoni for Treatment of Chronic Hepatitis C Infection

On Wednesday, September 4, 2019, the FDA announced new labeling changes to Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of chronic hepatitis C infection.

The changes encompass new dosage forms for Sovaldi for use in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin, and for Harvoni for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus.

A full rundown of the dosage forms for each medication is available here.

Baloxavir Marboxil Shows Promise in 2 Phase 3 Studies

In October 2018, the FDA approved baloxavir marboxil (Xofluza) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. The approval marked the first new antiviral flu treatment with a novel mechanism in nearly 2 decades.

On September 1, 2019, at the OPTIONS X Congress in Singapore, investigators from Genentech announced favorable results from 2 phase 3 trials of baloxavir marboxil, MINISTONE-2 and BLOCKSTONE, in a late-breaking session.

MINISTONE-2

The MINISTONE-2 study was a phase 3 trial that evaluated the pharmacokinetics and efficacy of 1 dose of baloxavir marboxil compared with oseltamivir in children <1 year to 12 years of age.

BLOCKSTONE

The phase 3 BLOCKSTONE trial was a randomized, post-exposure prophylaxis study that evaluated a single dose of baloxavir marboxil compared with placebo as a preventive treatment for individuals living with someone with an influenza infection confirmed by a rapid influenza diagnostic test.

The full story is available here.