AZ/FibroGen's Roxadustat Superior To Epoetin-Alfa In Chronic Renal Disease With Anemia
Positive top-line Phase III data from five studies, including the finding of superior efficacy to epotin-alfa, puts roxadustat in the driving seat as a new class of anemia agents heads toward the marketplace, but cardiovascular safety needs confirming.
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Roxadustat Approval Might Hinge On Additional Safety Analyses After FibroGen Admits Manipulating Data
With superiority over epoetin apparently off the table, FibroGen and AstraZeneca expect a US FDA advisory committee in July, and hope that additional safety analyses for roxadustat will help support a positive overall risk-benefit profile.
Switzerland’s leader in iron deficiency therapies wants to add new products in this and adjacent therapeutic areas, as strong revenue growth in 2018 backs its strategy of concentrating its efforts on the pharmaceuticals business.
The UK biotech has revised its business strategy over the past year, and Shield's CEO believes the company's lead product for iron deficiency is now well positioned to compete with current and potential entrants in the therapeutic sector.