Posted by Michael Wonder on 11 Jul 2021
UK’s MHRA accepts Humanigen’s submission of lenzilumab for marketing authorisation in COVID-19 for expedited rolling review
9 July 2021 - Humanigen today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdom’s MHRA for expedited COVID related rolling review, with assessment expected to occur more rapidly than a standard rolling review.
Leading up to initiating its submission for marketing authorisation last month, Humanigen held meetings with various authorities in the UK, including a Rapid C-19 multi-agency meeting with representatives from the MHRA, the Therapeutics TaskForce, the Department of Health and Social Care, National Health Service England and NICE.
