Restructuring On The Table For FibroGen After Roxadustat Rejection
As anticipated, the FDA issued a complete response letter for roxadustat. While the drug is expected to win EU approval, it is unclear if FibroGen and AstraZeneca will be willing to fund another trial.
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Months after a disappointment in Duchenne muscular dystrophy, the US firm’s pamrevlumab has missed the mark in a pivotal idiopathic pulmonary fibrosis trial, boding poorly for other trials and forcing the firm to enter cost-cutting mode.
MATTERHORN’s failure did not surprise analysts, but it’s likely the end of the road for roxadustat in the US market. The focus instead has shifted to FibroGen’s IPF asset pamrevlumab.
The US biotech is in the throes of an appeal to the FDA against the rejection of its HIF-PH inhibitor but regulators in the EU have looked more kindly on vadadustat, which will be sold as Vafseo.