September 2019

The U.S. Food and Drug Administration expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Mavyret is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.

Marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation to change the names of liposomal medicines, but only if there is a high risk of medication errors which would raise concerns regarding the safe use of the medicinal product.

EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities promptly so that appropriate regulatory actions can be taken.

U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.
Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation. These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.