Biotechnology major Biocon, an Indian pharmaceutical company, has received approval from the Drugs Controller General of India (DCGI) for their drug Itolizumab, a drug previously used to treat chronic plaque psoriasis, for treatment of moderate to severe COVID-19 patients in India.
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. Itolizumab, now repurposed for COVID-19 is a monoclonal antibody which was already in use for seven years to treat psoriasis.
How does it work
Cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) is a constellation of dramatic systemic symptoms caused by the rapid release of chemical substances called cytokines. It has been well described in cancer and transplant medicine, following treatment with a new class of drugs known as monoclonal antibodies.
The drug, Itolizumab, acts upstream in the body, gets the cells to stop producing cytokines and acts against at least three cytokines. Another monoclonal antibody Tocilizumab, from the Swiss major Roche and which is also being used for Covid, works downstream and manages the disease once the storm has kicked in.
When a person is infected with the coronavirus, the virus rapidly multiplies and progresses within the body, triggering an extreme reaction from the immune system. This is where Itolizumab helps — the intravenous injection works on toning down the aggressive response which can be self-damaging. In the 3-5% cases that get hospitalised for COVID-19, cytokine storm is the leading cause of death.
The approval of Itolizumab, from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals. The study focused on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19.
Things to know about Itolizumab
Itolizumab was originally discovered in Cuba; Biocon licensed it in 2003 and developed it in India for psoriasis.
Itolizumab, an anti-CD6 IgG1 monoclonal antibody was launched in India in 2013 under the brand name Alzumab to treat moderate to severe chronic plaque psoriasis.
The injection can be used as an immuno-moderator, in cases of emergency, to prevent and treat cytokine storms. Cytokines are small proteins secreted by immune cells to communicate and alter the actions of other immune cells. The SARS-COV-2 virus has been observed to induce an overreaction of the immune system, generating large numbers of cytokines that can cause severe damage to the lungs and other organs.
Since it helps to calm the immune system down, it needs to be given only in moderate to severe cases, when the patient needs oxygen support, and never in the early stages of viral attack.
The drug is administered as a single shot to moderate/moderately severe patients the moment it is suspected that they may need ventilator support.
Itolizumab will be manufactured and formulated as a 25 mg and 5 ml intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru, India.
Itolizumab will cost Rs 7,950 for vial; the entire treatment, which will be hospital-based, would cost around Rs 35,000 per patient (infusion).
As per the DCGI, the novel drug can be used only in hospital set-up and requires the consent of patients and a risk management plan.
