Zydus Cadila First Off The Block In NASH After India Approval
US Phase III Trials To Begin Q2 FY21
Cadila Healthcare has received the first approval globally, in India, for a NASH therapy, after the national regulator cleared its candidate saroglitazar. The company also expects to begin Phase III trials in the US in the second quarter of fiscal 2021.
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Zydus Cadila expects to launch its DNA COVID-19 vaccine in the first quarter of fiscal 2022 but it already has more advance purchase orders than it can produce. Meanwhile, the Indian firm is confident of saroglitazar being approved for primary biliary cholangitis in the US, with the NCE also poised to become the largest contributor to India sales in three to five years.
Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.
Zydus Cadila hopes to launch its version of Gilead’s remdesivir by end-July in India, even as earlier licensees Hetero Drugs and Cipla have just commercialized the antiviral. Plans for pegylated interferon alfa-2b to treat COVID-19 include a trial in Mexico and an IND in the US. Separately, desidustat is being considered for additional indications.