Back HCV Treatment Experimental HCV Drugs AbbVie's 3D Hepatitis C Combo Gets Priority Review in U.S. and Europe

AbbVie's 3D Hepatitis C Combo Gets Priority Review in U.S. and Europe

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AbbVie's all-oral 3-drug combination regimen for genotype 1 chronic hepatitis C has been granted priority review status by the U.S. Food and Drug Administration (FDA), putting it on track for approval by the end of the year. In related news, the company announced last week that Marketing Authorization Applications for the 3D regimen have been validated and are under accelerated assessment by the European Medicines Agency (EMA), with a decision expected in early 2015.

The 3D regimen consists of a trio of direct-acting antivirals that attack the hepatitis C virus (HCV) at different steps of its lifecycle: the HCV protease inhibitor ABT-450 boosted with ritonavir, the NS5A inhibitor ombitasvir (ABT-267), and the non-nucleoside HCV polymerase dasabuvir (ABT-333).

As reported at this year's EASL International Liver Congress in April, the 3D combination has demonstrated excellent sustained virological response (SVR) rates exceeding 95% for populations including treatment-experienced patientspeople with liver cirrhosis, and liver transplant recipients.

Below is an edited excerpt from an AbbVie press release describing the FDA decision in more detail. A release describing the EMA decision is available online.

U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C

North Chicago, Ill. -- June 13, 2014 -- AbbVie (NYSE: ABBV) announced today that the New Drug Application (NDA) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review.

The NDA was submitted on April 21, 2014 and is supported by data from a large clinical program including six Phase 3 studies of more than 2,300 GT1 patients in over 25 countries. The regimen was granted a Breakthrough Therapy designation by the FDA in May 2013, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.

In May 2014, AbbVie submitted marketing authorization applications (MAAs) for regulatory approval in the European Union.

About AbbVie's Investigational HCV Regimen

The AbbVie investigational regimen consists of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without RBV [ribavirin]. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.

Additional information about AbbVie's Phase 3 studies can be found on www.clinicaltrials.gov.

AbbVie's HCV Development Program

The AbbVie HCV 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, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C virus protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visitwww.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

its regimen could be available in the European Union in the first quarter of 2015. U.S. regulators have also granted the product priority review.

6/19/14

Sources

AbbVie. U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C. Press release. June 13, 2014.

AbbVie. European Medicines Agency Validates Marketing Authorization Application for AbbVie's Investigational, All-oral, Interferon-free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C. Press release. June 17, 2014.