AbbVie's Investigational Chronic Hepatitis C Treatment Granted Priority Review in Japan

AbbVie's Investigational Chronic Hepatitis C Treatment Granted Priority Review in Japan

- AbbVie's investigational, interferon and without ribavirin treatment in Japan comprises of a 12-week, two immediate acting antiviral, settled dosed blend of paritaprevir/ritonavir with ombitasvir, dosed once day by day

- New Drug Application, taking into account the Phase 3 GIFT-I study results in Japanese patients with genotype 1b hepatitis C infection (HCV) contamination, was submitted in February 2015

- GIFT-I met its essential endpoint, accomplishing 95 percent supported virologic reaction rate at 12 weeks post-treatment (SVR12); two patients (0.9 percent) stopped treatment because of antagonistic occasions

- Approximately 1.5 to 2 million individuals are living with hepatitis C in Japan(1); genotype 1 is most basic, representing 60 to 70 percent of all patients tainted with HCV(2)

Apr 15, 2015

NORTH CHICAGO, Ill., April 15, 2015/PRNewswire/ - AbbVie (NYSE: ABBV) today reported that the Japanese Ministry of Health, Labor and Welfare (MHLW) has allowed need survey for its investigational, two immediate acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. This all-oral treatment is interferon (IFN) and ribavirin (RBV)- free and will be dosed once every day. The MHLW gifts need survey to specific pharmaceuticals on the premise of clinical value and seriousness of the malady, including illnesses like hepatitis C, which influences give or take 1.5 to 2 million individuals in Japan.1 AbbVie's investigational hepatitis C treatment was submitted for advertising endorsement in Japan in February 2015. The New Drug Application is for the treatment of patients with genotype 1 (GT1) ceaseless hepatitis C infection (HCV) contamination and is upheld by the Phase 3 GIFT-I contemplate in Japanese genotype 1b (GT1b) HCV patients.

"AbbVie is satisfied that the Japanese MHLW has conceded need audit for our interferon and without ribavirin, 12-week, two immediate acting antiviral treatment regimen. This imprints another imperative headway in our HCV clinical advancement program as we mean to give our HCV treatment to patients over the world," said Scott Brun, M.D., VP, pharmaceutical improvement, AbbVie. "In the event that endorsed, AbbVie's HCV treatment holds the possibility to be a promising new treatment alternative for patients living with this incessant disease in Japan."

AbbVie mulled over a two immediate acting antiviral treatment regimen without RBV in Japan because of patient and viral qualities particular to the Japanese populace, including high predominance of GT1b. In Japan, GT1 is the most widely recognized HCV genotype and records for 60 to 70 percent of all patients contaminated with HCV.2 Of those patients, around 95 percent are tainted with the GT1b sub-type.2

Extra data about AbbVie's GIFT-I study can be found on www.clinicaltrials.gov.

About AbbVie's Investigational Two Direct-Acting Antiviral HCV Treatment

For the treatment of genotype 1 incessant hepatitis C infection (HCV) contamination in Japan, AbbVie's investigational, two immediate acting antiviral treatment comprises of the settled dosed blend of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once every day.

AbbVie's incessant HCV treatment consolidates two immediate acting antivirals, each with an unmistakable system of activity that objectives and represses particular HCV proteins of the viral replication process.

About AbbVie's HCV Clinical Development Program in Japan

AbbVie's HCV clinical improvement program in Japan concentrates on its investigational, two immediate acting antiviral treatment and is intended to accomplish high SVR rates in ceaseless HCV contaminated patients, including extra genotypes and patients with remunerated cirrhosis.

Paritaprevir was found amid the progressing joint effort in the middle of AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that incorporate protease inhibitors. Paritaprevir has been produced by AbbVie for utilization in mix with AbbVie's other investigational solutions for the treatment of hepatitis C.

Ombitasvir/paritaprevir/ritonavir is an investigational item and its security and viability have not been set up in Japan.

About AbbVie

AbbVie is a worldwide, examination based biopharmaceutical organization shaped in 2013 after partition from Abbott Laboratories. The organization's central goal is to utilize its mastery, devoted individuals and exceptional way to deal with development to create and business sector propelled treatments that address a portion of the world's most mind boggling and genuine illnesses. AbbVie utilizes more than 26,000 individuals overall and markets meds in more than 170 nations. For additional data on the organization and its kin, portfolio and duties, please visit www.abbvie.com. Take after @abbvie on Twitter or perspective vocations on our Facebook or LinkedIn page.

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