Biocon Biologics has received an emergency use authorisation (EUA) for its monoclonal antibody Itoliuzumab from the Drug Controller General of India (DCGI) to treat cytokine storms – one of the leading causes of death among patients with severe COVID-19.
As per the DCGI, the novel drug can be used only in a hospital set-up, and requires informed consent of patients and a risk management plan.
An EUA is usually given by a regulator if there is an urgent need for a treatment regime against a particular indication, and interim data from drug trial shows that it is safe and somewhat effective in treating that particular disease or its symptoms. However, an EUA is not equivalent to an approval, which is based on complete data.
Itolizumab was launched in 2013 under brand name Alzumab to treat moderate to severe chronic plaque psoriasis.
However, the indigenous drug has been repurposed for prevention and treatment of covid-19 complications after seven years of post-marketing safety data.
The Biocon Limited subsidiary had in May got an approval from the DCGI to run clinical trials in patients with the covid-19 complications.
“We believe the unique mechanism of action could help prevent and treat CRS or cytokine storm, seen as a complication of covid-19 that is responsible for the morbidity and mortality in these patients.
The clinical trial has been initiated at multiple hospitals in Mumbai and Delhi,” Sandeep Athalye, senior vice president and chief medical officer at Biocon Biologics, had told Mint on 1 June.
Cytokines are signalling substances, such as interferon, interleukin, and others, which are released by the immune system in response to a viral activity.
It has been observed that the novel coronavirus infection, in certain cases, causes an overproduction of cytokines, which can lead to excessive inflammation, organ failure and eventually death.
A statement from Biocon Biologics is awaited.