DCGI approves limited use of psoriasis injection for Covid-19

Itolizumab is a monoclonal antibody approved for the treatment of severe chronic plaque psoriasis. Monoclonal antibodies are lab-made proteins that act like human antibodies in the immune system and fight against foreign molecules.

The Drugs Controller General of India (DCGI) has approved restricted emergency use of Itolizumab injection for treating moderate to severe coronavirus disease (Covid-19) cases. The approval has been granted based on clinical trial data that has shown promise, officials aware of the matter said.

The drug is manufactured and marketed by Biocon for the treatment of patients with moderate to severe chronic plaque psoriasis. It has been in use since 2013 under the brand name of Alzumab. (AP)

Itolizumab is a monoclonal antibody approved for the treatment of severe chronic plaque psoriasis. Monoclonal antibodies are lab-made proteins that act like human antibodies in the immune system and fight against foreign molecules.

The drug is manufactured and marketed by Biocon for the treatment of patients with moderate to severe chronic plaque psoriasis. It has been in use since 2013 under the brand name of Alzumab. This indigenous drug has now been repurposed for Covid-19 treatment.

In a statement, the Union health ministry on Saturday said Biocon presented the phase II clinical trial results generated in Covid-19 patients to DCGI. “The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office. Details of primary endpoint of mortality, other key endpoints of lung function such as improvement in PaO2 and O2 saturation were presented. Key inflammatory markers IL-6, TNFα etc., were presented to have reduced significantly with the drug thereby preventing hyper-inflammation in COVID-19 patients.”

The committee looked into the data related to the drug for its impact on Covid-19 patients. “After detailed deliberation and taking into account the recommendations of the Committee, DCGI has decided to grant permission to market the drug under Restricted Emergency Use of the drug for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients due to COVID-19…,” the ministry statement said.

The emergency use authorisation involves fulfilment of certain conditions. They include taking informed written consent of patients and apprising them of risks and benefits of the drug and putting a risk management plan in place to manage any adverse effects. The drug is to be given only in hospitals and medical institutions and is not meant for sale at retail pharmacies.

“This is done to protect the misuse of [such a] drug as it must be given under strict medical supervision,” said an official in the DCGI’s office.

The health ministry said the drug is also cheaper than the other repurposed medicines approved for the treatment of Covid-19. “The average cost of treatment with this indigenous drug is also lesser than comparable drugs that are part of the ‘investigational therapies’ indicated in the clinical management protocol for Covid-19.”

The drugs approved for use in Covid-19 treatment in India include antivirals such as remdesivir, and immunosuppressant tocilizumab, steroid dexamethasone, and anti-malarial hyrdoxychloroquine.

Medanta Hospital’s critical care department chairman Dr Yatin Mehta said there is no specific medication for Covid-19 at the moment and world over these medicines are being tried to treat hospitalised patients. “However, there are certain contraindications in the use of these medicines. So, the medicine is not for everyone and needs to be started under strict medical supervision.”

“Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. Biocon has repurposed Itolizumab… for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19,” said Biocon Ltd. in a statement.

“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 in Mumbai and New Delhi. The study focussed on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19. The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.”

Kiran Mazumdar-Shaw, executive chairperson, Biocon, said: “As an innovation-led biopharmaceuticals company, I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper immune response seen with COVID-19. The data is compelling and I am confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country.”

The drug will be manufactured and formulated as an intravenous injection at Biocon’s bio manufacturing facility at Biocon Park, Bengaluru. The company plans to take this therapy to other parts of the world impacted by the pandemic.

“At the time of this COVID-19 pandemic, we do not have any specific treatment for patients who are losing the fight against the disease in spite of best supportive care. Lok Nayak Hospital was one of the sites of the Itolizumab study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose of Itolizumab. Patients who were with initial oxygen saturation of less than 80% and would have been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged…,” said Dr Suresh Kumar, medical director, Lok Nayak Hospital, in a statement.