Gilead Sciences, Inc. (NASDAQ:GILD) released a press note today stating that it has presented a New Drug Application (NDA) before Japanese Pharmaceutical and Medical Devices Agency (PMDA). The NDA is filed to seek approval for the company’s tenofovir alafenamide (TAF) drug, which is developed to treat hepatitis B virus infection (HBV).
Better than Viread
The company claims that the TAF drug is equivalent to Viread (tenofovir disoproxil fumarate, TDF), which is currently marketed in Japan by GlaxoSmithKline plc (ADR) (NYSE:GSK). It added that TAF is less stressful on bones and kidneys, and just one-tenth of the drug’s dose provides equal efficacy as Viread. The drug will mark a key product in the company’s pipeline given its ability to capture a huge market share in Japan, where more than 1 million people are infected with HBV.
The NDA is backed by a 48-week long two separate Phase 3 studies, which succeeded in meeting primary objective of non-inferiority in efficacy. Several patients from Japan were enrolled in the study and those treated with TAF showed significant improvement while reporting a smaller decrease in bone mineral density in hip and spine bones at the conclusion of Week 48. Moreover, the ratio of adverse events for TAF was more or less similar to that of Viread.
Development in the U.S. and Europe
It is noteworthy that the company has already received approval for TAF from the U.S. Food and Drug Administration for the treatment of HIV-1 in March. Meanwhile, the marketing applications of the drug for treatment of HBV is currently under review in the U.S. and Europe. The NDA by Gilead will come as a setback to ContraVir Pharmaceuticals Inc (NASDAQ:CTRV), which had created hype after stating the results of a third-party laboratory study that showed its CMX157 performed better than TAF.
The stock price of Gilead Sciences fell 0.25% to $91.97 during the previous session.