FibroGen (FGEN -5.5%) slips on below-average volume in early trade in apparent response to a bearish report from Plainview LLC who questions the safety profile of lead drug roxadustat and efficacy of candidate #2 pamrevlumab.
Plainview says the rate of major adverse cardiovascular events (MACE), a composite measure of all-cause mortality, heart attacks and strokes, associated with roxadustat may not be as good as erythropoietin (EPO) analogs (e.g., Amgen’s Epogen) in dialysis-dependent chronic kidney disease (DD-CKD) patients or placebo in non-dialysis-dependent CKD patients (NDD-CKD). To earn an FDA nod, the data will need to demonstrate roxadustat’s MACE non-inferiority (no worse than) to both.
The company has stated that there are no “clinically meaningful differences” in MACE risk between roxadustat and EPO in DD-CKD and placebo in NDD-CKD but Plainview cites published data that showed large MACE and death imbalances, claiming that the company is keeping the negative results under wraps.
As far as pamrevlumab is concerned, Plainview is unconvinced that it has a role treating anything, doubting positive outcomes from late-stage studies in idiopathic pulmonary fibrosis (data readout in 2022) and locally advanced pancreatic cancer (readout in 2023), adding that the company is only conducting one trial in each so another study will be needed to support a U.S. marketing application for either indication, meaning potential approval is probably 9-10 years away.
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