Therapy Areas: Autoimmune
UK's MHRA accepts Humanigen's Submission of Lenzilumab for Marketing Authorization in COVID-19 for Expedited Rolling Review
9 July 2021 - - US-based biopharmaceutical company Humanigen, Inc's (NASDAQ: HGEN) submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdom's Medicines and Healthcare Products Regulatory Agency for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review, the company said.

Leading up to initiating its submission for Marketing Authorization last month, Humanigen held meetings with various authorities in the UK, including a Rapid C-19 multiagency meeting with representatives from the MHRA, the Therapeutics TaskForce, the Department of Health and Social Care, National Health Service England and the National Institute for Heath and Care Excellence.

According to Public Health England, despite the first dose vaccination rate of 86% across the UK, the current seven-day hospitalization rate was nearly 2,500, representing a 45% increase over the prior period.

Deaths from COVID in the UK reached 161 over the last seven days, an increase of more than 40% compared to the prior seven-day period.

Humanigen, Inc. (NASDAQ: HGEN) a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called 'cytokine storm'.

Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF).

Results of preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm.

Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission.

Humanigen's Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

Humanigen is developing lenzilumab as a treatment for cytokine storm associated with CD19-targeted CAR-T cell therapies and exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis.

Humanigen is also developing a portfolio of clinical and pre-clinical therapies for the treatment of inflammation and immuno-oncology.


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