AbbVie Inc (NYSE:ABBV) Records CHMP Positive Feedback For MAVIRET™

AbbVie Inc (NYSE:ABBV) reported that the European CHMP of the European Medicines Agency has granted a promising opinion suggesting marketing approval of MAVIRET™, an investigational, pan-genotypic therapy for adults with chronic HCV infection.

If authorized, MAVIRET will be a ribavirin-free, once-daily, 8-week alternative for people without cirrhosis and who are new to therapy across all genotypes, who constitute the majority of people struggling with HCV.1 As per the latest update, the European Commission will assess the CHMP opinion and a final outcome is projected in Q3 2017.

The highlights

Michael Severino, M.D., the Chief Scientific Officer and the EVP of R&D at AbbVie, reported that MAVIRET showcases a new generation of HCV treatment and has the prospect to be an 8-week option for people living with this grave, chronic illness. Today’s CHMP positive stance takes them closer to delivering on company’s objective to address continued unmet needs by getting a new pan-genotypic alternative to people struggling with HCV in Europe.

The CHMP positive opinion is backed by 97.5% SVR12 rates with eight weeks of MAVIRET in GT1-6 chronic HCV infected people minus cirrhosis and who are new to therapy, with diverse patient and viral characteristics. In an integrated assessment, less than 0.4% of people discontinued treatment. The announced adverse reactions were fatigue and headache. The severity and type of adverse reactions in people with cirrhosis were comparable to those noticed in patients without cirrhosis.

While the HCV treatment scope has transformed considerably over recent years, the disease remains to be an international public health problem and treatment concerns remain. Stefan Zeuzem expressed that in clinical trials, MAVIRET showed high SVR rates in different genotypes of HCV patients. If permitted, MAVIRET would eliminate many of the complications of pre-treatment patient assessment and possess the potential to help support the management and care of HCV.