Humanigen Inc. (NASDAQ: HGEN) has announced the appointment of a co-rapporteur and rapporteur by the EMA as part of the pre-submission course associated with the company’s plan to submit MAA for lenzilumab use in treating hospitalized patients with COVID-19.
Appointments vital for MAA submission
The Committee for Medicinal Products for Human Use appointments are vital in the pre-submission step leading to an MAA submission. The company is planning to request for expedited MAA assessment as part of the process of pre-submission.
CEO Cameron Durrant said, “Highlighting the ongoing need globally for therapeutics to treat patients hospitalized with COVID-19, in the EU in the most recent week for which data is available, there were 7,664 new hospitalizations and 4,429 deaths reported for COVID-19. We remain committed to bringing lenzilumab to hospitalized patients with COVID-19 and as part of this effort, we plan to submit our MAA to the EMA as soon as possible.”
If CHMP determines a product is a significant public health interest, EU legislation permits accelerated review of an MAA, reducing evaluation time from 210 to 150 days. There is no inclusion of clock stops for applicants to offer additional information. However, the decision has no bearing on the CHMP’s final opinion on whether MAA should be approved.
Lenzilumab regulates various inflammatory chemokines and cytokines
Lenzilumab is a novel antibody that binds to granulocyte-macrophage colony-stimulating factor (GM-CSF) and neutralizes it. According to preclinical models, GM-CSF is an upstream regulator of several inflammatory chemokines and cytokines involved in the cytokine storm. Investigations early in the COVID-19 pandemic revealed that high levels of GM-CSF secreting T cells were linked to disease severity and ICU hospitalization. Early intervention with lenzilumab, according to Humanigen’s third phase LIVE-AIR trial, may avert the effects of a full-scale cytokine storm.
The company has submitted lenzilumab to the UK’s Medicines and Health Regulatory Agency for a rolling evaluation in the hopes of gaining Marketing Authorization.