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Restricted Emergency Use of Itolizumab gets DCGI approval

Restricted Emergency Use of Itolizumab gets DCGI approval

The Drugs Controller General of India (DCGI) has approved the Restricted Emergency Use of Itolizumab (rDNA origin), a monoclonal antibody that has been already granted authorisation for severe chronic plaque psoriasis on the basis of clinical trials.

Key Points:

  • The drug has been manufactured and marketed by M/s Biocon since 2013, for the treatment of patients that have moderate to severe chronic plaque psoriasis as Alzumab.
  • The drug has been repurposed now for COVID-19.
  • Details of the result of Phase II clinical trials were deliberated in the Subject Expert Committee of DCGI’s office.
  • On the basis of detailed discussions and suggestions of the Committee, permission to market the drug for treating Cytokine Release Syndrome (CRS) in moderate and severe Acute Respiratory Distress Syndrome (ARDS) patients as a result of COVID-19 was granted by DCGI.
  • The administration of the drug will be on the condition that the informed consent of the patient will be necessary along with a risk management plan that has to be followed in a hospital set up only.
  • The treatment with the indigenous drug costs very less in comparison to drugs that are part of “Investigational Therapies” given by the Ministry of Health and Family Welfare in the Clinical Management Protocol for COVID-19.

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