Zydus Cadila Strides Ahead With NASH Filing In India
API Manufacturing Unit In Dabhasa Receives NAI
Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.
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Cadila is exploring orphan indications for saroglitazar magnesium, in addition to the approaching Phase III NASH clinical trials for its lead NCE. Meanwhile, it counts on new product launches and biosimilars to take its FY21 growth story ahead.
Atypical histological findings from a Phase IIb NASH study lead CymaBay to terminate mid-stage studies in NASH and PSC and place a Phase III PBC trial on hold.
Zydus says its Moraiya plant should be ready for re-inspection at the end of June 2020, following a recent FDA warning letter. Meanwhile, as returns from levorphanol fall on the back of increased competition, the firm has written down investment by $37.5m causing Q2 profits to slump 74%. Post successful Phase II trials in the US for NASH and NAFLD indications, its hopes are now pinned on saroglitazar magnesium.