Biocon to market Itolizumab for emergency use in India

Biocon's Itolizumab gets DCGI nod for its use in moderate to severe COVID-19 patients

DCGI gives nod for restricted emergency use of Itolizumab injection on COVID-19 patients

Biocon, a domestic biopharmaceutical company, has been manufacturing and marketing Itolizumab, a monoclonal antibody drug, for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under the brand name Alzumab, the health ministry said.

India's drug regulator has authorised Itolizumab, a drug used to remedy pores and skin ailment psoriasis for "restricted emergency use" to deal with COVID-19 sufferers with reasonable to extreme acute respiratory misery, officers informed PTI on Friday.

Drugs Controller General of India Dr VG Somani approved an injection of the drug to treat cytokine release syndrome among coronavirus patients.

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He noted that "the idea that the virus is mutating and so is less damaging to people, has not yet been proven at all". I think it would not be viewed very favorably, even by the states and the cities involved.

A committee comprising of various medical experts from All India Institute of Medical Sciences (AIIMS) were of the view that Itolizumab was found to be satisfactory for treatment of cytokine release syndrome in COVID-19 patients.

The firm presented the phase II clinical trial results to the drug regulator which were deliberated upon by the Subject Expert Committee of the DCGI's office.

Details of the primary endpoint of mortality, other key endpoints of lung function such as improvement in partial pressure of oxygen and oxygen saturation were presented.

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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.

Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, it added. The immune system is hyperactive and uncontrolled in Covid-19; it produces excess cytokines, T-cells and antibodies. Drugs that are now being repurposed and experimented for COVID-19 aim to calm this storm down, and save the patient. These drugs include Remdesivir and Tocilizumab, both of which are exorbitantly priced.

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