Covid-19: Nod for psoriasis drug to be used for coronavirus patients

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July 12, 2020 7:30 AM

The average cost of treatment with this indigenous drug is also lesser than comparable drugs that are part of investigational therapies indicated in the clinical management protocol for Covid-19 of the health ministry, DCGI added.

Biocon’s Itolizumab (rDNA origin) is a monoclonal antibody that is already an approved drug for severe chronic plaque psoriasis.

The Drug Controller General of India (DCGI) has granted permission for restricted emergency use of Itolizumab injection for moderate to severe Covid-19 patients following the rising number of cases across the country. The approval to use this injection was given based on the clinical trials data submitted by biotech major Biocon, which revealed that key inflammatory markers reduced significantly with the drug, thereby preventing hyper-inflammation in Covid-19 patients.

Biocon’s Itolizumab (rDNA origin) is a monoclonal antibody that is already an approved drug for severe chronic plaque psoriasis. “Itolizumab, a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted restricted Emergency Use Authorisation (EUA) based on clinical trials data,’’ DCGI said in a statement.

Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name Alzumab. This indigenous drug has now been repurposed for Covid-19. Biocon has 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 end point of mortality and key points of lung function were presented.

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, with some conditions like informed consent of patients, a risk management plan, to be used in hospital set up only, etc.

The average cost of treatment with this indigenous drug is also lesser than comparable drugs that are part of investigational therapies indicated in the clinical management protocol for Covid-19 of the health ministry, DCGI added.

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