Novartis’s Fabhalta Reaches First Stop On Regulatory Journey With PNH Nod
Novartis envisions the drug, the first oral monotherapy for PNH, as a “pipeline in a pill” that could see $3bn in peak sales, with a Phase III readout in IgAN in October and one in C3G expected this month.
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The pricing watchdog said 94% of Fabhalta’s price comes from offsetting the cost of AstraZeneca’s Ultomiris, while Novartis said ICER’s analysis has “substantial challenges.”
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