New Delhi: Based on clinical trials data, India's drug regulator has approved itolizumab, used to treat skin condition psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory distress, the Union health ministry said on Saturday.
Considering the unmet medical needs in COVID-19, Drugs Controller General of India (DCGI) Dr V G Somani had on Friday approved itolizumab injection for use in the treatment of coronavirus 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.
"This indigenous drug has now been repurposed for COVID-19," it said in a statement.
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.
"After detailed deliberation and taking into account the recommendations of the committee, the DCGI has decided to grant permission to market the drug under restricted emergency use for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome patients due to COVID-19," it said.
The use of the medicine is subject to some conditions including requirement of informed consent of patients, a risk management plan and usage only in hospital setup.
The average cost of treatment with this indigenous drug Itolizumab is lesser than other medicines which are part of investigational therapies indicated in the health ministry's Clinical Management Protocols for COVID-19.