Welcome to this week’s FiercePharmaAsia report, which includes an upcoming new drug application by FibroGen and AstraZeneca in China, a ruptured eardrum med's rights transfer to Astellas, and Takeda's single-digit price-hike promise.
FibroGen has posted positive phase 3 data on its anemia drug roxadustat carried out in China and is on the move for an approval in the country. With a “green channel” fast regulatory process, FibroGen plans to complete the NDA later this year. Once approved, FibroGen will handle manufacturing, and its partner AstraZeneca will focus on the launch and commercialization.
Astellas has obtained worldwide rights to AU-935 from Auration Biotech. The drug, first discovered at Stanford University, could be used to make eardrums regenerate, therefore providing an alternative to surgery for tympanic membrane perforation, commonly known as a ruptured eardrum. Another Japanese drugmaker Nobelpharma is also in the latter stages of developing a formulation for the disease.
Takeda just joined three other pharma companies—Allergan, Novo Nordisk and AbbVie—that promise to keep yearly drug price increment below 10%. Merck, though making no specific promises to set a number, recently released a Pricing Action Transparency Report showing their increases have been modest.