FDA to Chiasma on their Phase III rejection: Come up with a better plan next time
The FDA really, really, really doesn’t like Chiasma’s Phase III study for its lead drug, octreotide. And the biotech isn’t making much headway in finding a way around the regulatory roadblock without satisfying the agency’s demand for a new, far better designed Phase III trial.
Regulators at the agency batted down the acromegaly drug, dubbed MyCapssa, last April after concluding that the biotech simply didn’t prove that the pill works with the single-arm Phase III on offer. The oral drug is intended to replace the injected therapies currently used to treat the rare hormone ailment, in which the pituitary gland generates too much hormone. And regulators don’t appear to be too receptive to any alternative plans that Chiasma has in mind. From the biotech’s 10Q:
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