As FDA door shuts on its PI3K, MEI Pharma throws in the towel, lays off staff
Having steered a PI3K inhibitor from preclinical studies all the way to Phase II, San Diego’s MEI Pharma is all but washing its hands of the drug as the FDA raises the bar on the class.
The biotech is discontinuing development of zandelisib everywhere except Japan, where its partner Kyowa Kirin will move forward with ongoing trials and explore an approval based on Phase II data. While MEI Pharma had originally hoped to do the same in the US, the FDA put its foot down and asked for a new clinical trial — which it decided isn’t worth the effort.
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