J&J Prepares For US Sirukumab Launch After Regaining Rights From GSK
GSK returned US rights to the IL-6 blocker to J&J as it prioritizes its pharma portfolio under the leadership of new CEO Walmsley.
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Janssen-Cilag has withdrawn the EU marketing application for the IL-6 inhibitor sirukumab, with the CHMP saying the long-term safety of sirukumab had not been well characterized and further clinical studies were required, a conclusion also drawn earlier by the US FDA.
The company said it will pull global regulatory filings for the interleukin-6 inhibitor sirukumab for rheumatoid arthritis after determining regulatory delays would put it too far behind the competition.
FDA advisory committee's concerns about a mortality imbalance in Plivensia clinical trials would appear to reduce the odds that the interleukin-6 inhibitor will reach the US market in the near term.