AbbVie submits NDA in Japan for investigational.

Related StoriesMylan announces U.S. Launch of generic Fusilev for InjectionNovo Nordisk announces FDA acceptance of Tresiba for diabetes treatmentAllergan settles patent litigation with Amneal linked to NAMENDA XR expanded release capsules We are pleased to announce the regulatory submission of our two direct-acting hepatitis C antiviral treatment in Japan, which comes after on quickly from latest approvals of our three direct-acting antiviral treatment in the U.S., Canada and europe, said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. This submission is founded on a large Phase 3 study in multiple affected individual types and brings us nearer to offering the chance of cure for individuals with chronic genotype 1b hepatitis C infection, the most typical form of the disease in the country.Statistical Analysis We assessed the principal noninferiority hypothesis by determining whether the upper boundary of the two-sided 95 percent self-confidence interval of the hazard ratio for the chance of the primary composite cardiovascular outcome didn’t exceed 1.30 in the sitagliptin group, as compared with the placebo group, in the per-protocol population, with a key supporting analysis in the intention-to-treat population. The statistical analysis program prespecified that the following hypotheses be examined in a sequential manner: noninferiority for the primary composite cardiovascular outcome , noninferiority for the secondary composite cardiovascular outcome in the per-protocol analysis, superiority for the primary composite cardiovascular outcome in the intention-to-treat evaluation, and superiority for the secondary composite cardiovascular result in the intention-to-treat analysis.