The FDA indicated the drug couldn’t be approved in its present form and asked for another clinical trial of the drug be run before they reapplied.
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The U.S. Food and Drug Administration (FDA) issued FibroGen a Complete Response Letter (CRL) for its New Drug Application (NDA) for roxadustat. The company was hoping the drug would be approved for the treatment of anemia in patients with chronic kidney disease (CKD).
The FDA indicated the drug couldn’t be approved in its present form and asked for another clinical trial of the drug be run before they reapplied.
“We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of CKD in the United States,” said Enrique Conterno, chief executive officer of FibroGen.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has offered a positive opinion, with a decision expected by the end of this month.
Roxadustat is an oral HIF-PH inhibitor that promotes the production of red blood cells. It does so by increasing endogenous production of erythropoietin, improving iron absorption and mobilization, and downregulating hepcidin. It is also being developed for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).
The outcome was probably not a complete surprise. On July 15, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted not to approve the drug for this indication. The adcom based its decision on data from a global Phase III program of more than 8,000 patients.
At the company’s second-quarter financial report on August 9, Conterno said, “We continue to be energized by the performance of Roxadustat in China, where we are seeing impressive adoption of Roxadustat in a rapidly expanding anemia of CKD market. In addition, the positive CHMP opinion in Europe brings Roxadustat one step closer to patients in this important region. We look forward to the European Commission decision following the positive CHMP opinion.”
Net product revenue for Roxadustat in China for the quarter was $13.4 million, which included revenue from sales to their distributor as well as FibroGen China’s direct sales. The numbers were slightly down from $15.4 million in the first quarter of the year. Total Roxadustat net sales in China were $52.8 million by FibroGen and the distributor that is jointly owned by FibroGen and AstraZeneca.
The company is expecting data in the third quarter from the Phase II Whitney study of the drug in CIA, and topline data from the Phase III Matterhorn trial of Roxadustat in anemia of MDS in the second half of 2022 or the first half of 2023.
Otherwise, the company reported a net loss for the quarter of $133.9 million and a loss of $206.1 million for the first half of the year. Research and development expenses for the quarter were $122.6 million and $197.2 million for the half-year mark.
Astellas and FibroGen are working together and developing and commercializing Roxadustat for anemia in various markets, including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. With AstraZeneca, it is developing the drug for anemia in the U.S., China, other markets in the Americas, Australia and New Zealand, and Southeast Asia.
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