Enanta Pharmaceuticals Inc (NASDAQ:ENTA) has disclosed that the European Commission has granted AbbVie Inc (NYSE:ABBV) authorization to market Maviret, a treatment aimed at adult patients suffering from chronic hepatitis C. The biotechnology company that is based in Watertown, Massachusetts now stands to receive a milestone payment of $25 million from Abbvie. Maviret is specifically targeted at those just starting treatment and who are not suffering from cirrhosis.
“Maviret represents an innovation in HCV care as an 8-week, pan-genotypic option that combines two distinct antiviral agents and has high efficacy even against most genotypes commonly associated with resistance to treatment,” said the chief scientific officer and the research and development executive vice president of Abbvie, Michael Severino.
Specific treatment challenges
An indication for Maviret has also been given for patients who have specific treatment challenges. This includes those patients suffering from chronic kidney disease.
Prior to getting the approval, eight registrational studies were undertaken in a clinical development program run by AbbVie for over 2,300 patients in 27 countries. The studies found that there was a 97.5% cure rate within a period of eight weeks in those patients who were not suffering from cirrhosis and who had just begun treatment. In the case of compensated cirrhotic patients, there was a 98% cure rate within a treatment period of 12 weeks.
For patients who had been undergoing GT3 treatments, there was a cure rate of 96% which was achieved within a treatment period of 16 weeks. The level of patients who discontinued treatment as a result of adverse reactions was 0.1% with fatigue and headaches being the most common side effects.
Maviret was approved under an accelerated assessment review conducted by the European regulator when new medicines are of a major public interest. Other countries where Maviret has been granted an accelerated review designation includes Japan and the United States. The approval now allows Maviret to be sold in all European Union countries as well as Norway, Liechtenstein and Iceland.
On Tuesday shares of Enanta Pharmaceuticals Inc rose by 1.02% to close the day at $38.50.