Optum is closely watching resmetirom, a pill that could be the nation’s first approved therapy for nonalcoholic steatohepatitis, which affects at least 2 million Americans. The FDA plans to decide by March 14.
It operates by reducing excess liver fat and the formation of fatty plaques in the arteries, and surrogate outcomes look promising as an ongoing trial tests how a patient feels, functions and survives.
The other drug candidate nearing an FDA approval decision is sotatercept. It’s an experimental injectable that might be approved by March 26 to treat adult patients with pulmonary arterial hypertension.
Sotatercept works by “restoring the proper balance between normal cell growth or encouraging natural cell death,” Optum said. Its short-term trial results are promising, and its competition, Uptravi, has a wholesale acquisition cost of $260,000 a year.
Optum was also keeping tabs on roluperidone, an experimental schizophrenia medication, which the FDA rejected for the second time on Feb. 27.
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