On Friday, the Food and Drug Administration approved a pill called Orenitram, to treat pulmonary arterial hypertension. It is an oral version of an injected drug called Remodulin, which treats the same disease. According to Mark Schoenebaum at ISI Group, the approval is “an enormous surprise — arguably, one of the top 10 biggest upside surprises in the history of the biotech sector.”
Why? Well, for one thing, Orenitram’s benefit isn’t that compelling. The FDA-approved labeling for the product characterizes the treatment effect as “small.” And the FDA had already rejected it twice, in March and October 2012. It seemed nearly impossible that the medicine would be approved without additional data. Yet that’s exactly what has happened.
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