The U.S. FDA granted priority review status to AbbVie Inc (NYSE:ABBV)’s hepatitis C drug to treat adult patients suffering with chronic genotype 4 hepatitis C. It is a key achievement for the company as competition among developers of hepatitis drugs intensifies. The new status reduces the regulatory review period to just six months.
The treatment
AbbVie’s treatment drug is the first oral, interferon-free medication under FDA assessment for patients suffering with the specific strain of the virus. There are as many as six different strains of hepatitis and Genotype 1 can be stated as the most common type of hepatitis strain found in the U.S. The other strain genotype 4 is common in Egypt, Africa and the Middle East. As per the “National Center for Biotechnology Information” the epidemiology of hepatitis strain ‘Genotype 7’ has altered and has commenced to spread to several other regions in Europe through injection drug use and immigration.
The designation
The U.S. FDA gives priority review status to investigational drugs that cure a serious condition and, if accepted, would offer a considerable improvement in effectiveness or safety. This status reduces the regulatory review period to six months compared to review period of at least ten months. AbbVie’s treatment was also given a breakthrough therapy status in June 2014, a designation granted to investigational therapies for life threatening or serious conditions with initial clinical data that may reflect considerable improvement compared with available treatment.
The significance
AbbVie Inc (NYSE:ABBV) stated that the priority status was received on basis of results from its Pearl-I study, performed in 2014, which demonstrated a 100% treatment rate for previously untreated patients or in patients in whom available treatment failed. The treatment period was 12 weeks during which patients were administered with two direct-acting antivirals. There are almost 34 million people across the globe who suffers from Genotype 4 chronic hepatitis C.
