Japan Again Postpones Approval Of Shionogi COVID Antiviral
Decision To Await Phase III Data
Xocova’s emergency approval stymied by uncertainties over efficacy and other characteristics that could effectively limit its use, prompting decision to await Phase III data later this year.
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The first sublicensing deals through MPP for Shionogi's oral COVID antiviral Xocova with seven firms in China, India, Ukraine and Vietnam suggest the global debut of generic versions will come earlier than usual after the original, which continues in multiple global Phase III programs in various settings. While sales hopes are high, the drug may also be hit by a price cut in its first and biggest market so far – Japan.
As Japan's pharma market continues to face supply chain challenges and rising healthcare costs, regulatory authorities are looking to policies that balance incentives in critical areas and temporary price rises with other other ongoing measures to contain the national drugs bill. The Pink Sheet takes a look at the key changes last year and what to expect in 2023.
Shionogi’s once-daily oral COVID-19 antiviral finally gets Japan approval after being considered for the third time by an expert panel, paving the way for public availability of the country’s first such home-grown option in early December.