The FDA has granted priority review for a New Drug Application submitted by AbbVie Inc. for its all-oral, interferon-free therapy for patients with chronic genotype 1 hepatitis C virus infection.
The US Food and Drug Administration (FDA) has granted priority review for a New Drug Application (NDA) submitted by AbbVie Inc. for its all-oral, interferon-free therapy for patients with chronic genotype 1 hepatitis C virus infection, the company announced.
The investigational regimen outlined in the NDA was granted breakthrough therapy designation by the FDA one month after it was submitted in April, according to a news release issued by AbbVie at the time. Meanwhile the drug maker announced this week that it also obtained accelerated assessment from the European Medicines Agency (EMA) for evaluation of the same investigational drug.
A faster review time granted by the FDA could bring the drug to the US market earlier if the application is ultimately approved. The agency grants the designation for drugs that would significantly improve the safety or effectiveness of the treatment of a serious condition when compared to standard applications.
The NDA is for an all-oral, interferon-free drug regimen for adults with chronic genotype 1 hepatitis C infection. It includes data from six phase 3 international clinical studies with more than 2,300 patients in more than 25 countries.
If approved, the AbbVie oral regimen is staged to compete in a growing market of newer hepatitis C drugs with high cure rates that work faster with less serious side effects. Traditional treatment of the virus involves injections with interferon that often cause severe flu-like symptoms that discourage some patients from seeking treatment.
Hepatitis C is a blood borne virus that can severely damage the liver and cause cirrhosis or liver cancer and lead to the need for a liver transplant. Health officials estimate there are up to 150 million people worldwide, including more than 3 million in the U.S. who have chronic hepatitis C infection from the virus, which is spread from person to person mostly by tainted needles or other drug injection materials but also from sexual transmission with an infected person.
The AbbVie investigational regimen submitted for regulatory approval in the US and Europe is a fixed-dose combination of ABT-450/ritonavir (150/100 mg) co-formulated with ombitasvir (ABT-267) 25 mg, dosed once daily, and dasabuvir (ABT-333) 250 mg with or without RBV (weight-based), dosed twice daily. The trio of mechanisms of action stops replication of the hepatitis C virus with the goal to improve sustained virologic response rates across different patient populations.
The Marketing Authorization Applications (MAA) submitted to the EMA have been validated after receiving accelerated assessment granted for new medicines of major public health interest, AbbVie announced in a separate statement. Validation confirms that the submissions are complete and begins the EMA’s review process, which could land the drug, if approved, on the market in the first quarter of 2015.