The Food and Drug Administration (FDA) has accepted AbbVie's new drug application and granted priority review for its experimental all-oral regimen for treating adult patients infected with the most common strain of the hepatitis C virus (HPV).
The FDA first granted breakthrough therapy designation to AbbVie's investigational treatment for chronic genotype 1 hepatitis-C in May 2013. Breakthrough therapy status means the regimen has already been supported by preliminary clinical evidence that shows it leads to better results than conventionally accepted treatments. In this case, the AbbVie treatment is backed by six phase III studies of more than 2,300 patients of hepatitis C in more than 25 countries.
A drug application under priority review means the FDA has six months to evaluate the safety and effectiveness of the AbbVie regimen before it lays down its verdict on whether the drug manufacturer may or may not take its product to market.
The Illinois-based drug-maker, which separated from Abbott Laboratories last year, also filed its marketing authorization applications for approval by the European Union.
"The AbbVie clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible," says AbbVie in a news release.
The new regimen consists of an antiviral called ritonavir and a protease inhibitor called ABT-450, which was discovered by AbbVie in cooperation with Enanta Pharmaceuticals, combined with an NS5A inhibitor called ombitasvir and the polymerase inhibitor dasabuvir. The regimen is formulated with and without ribavirin, an antiviral drug that inhibits HPV's ability to replicate. When taken together, these three different mechanisms are powerful enough to stop the HPV virus in its tracks.
Interferon therapy is considered one of the most common treatments for hepatitis C. It is administered through injections and stimulates the activity of the immune system. Because the laboratory-created interferon used for HPV pushes the body's immune cells to take action against the virus, the concentrated amount of the synthetic protein in the system causes flu-like symptoms, such as fever, headache and fatigue. In extreme cases, the drug can cause severe side effects such as depression, decreased white blood cells and elevated liver enzymes. Using interferon therapy and a combination of drugs, patients normally had to wait six months to be completely healed.
If approved, AbbVie's regimen would compete directly with Gilead's all-oral HPV treatment, which is made from a combination of its popular Sovaldi drug and the NS5A inhibitor ledipasvir. Gilead's treatment has yet to receive approval from the FDA.
