News National DCGI approves 'Itolizumab' to treat severe Covid-19 patients under restricted emergency use

DCGI approves ‘Itolizumab’ to treat severe Covid-19 patients under restricted emergency use

Global Coronavirus casesItolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency use in treating Covid-19 by the Drugs Controller General of India (DCGI) based on clinical trials data.

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.

Read More:- How consuming tobacco can affect your health during Coronavirus pandemic ?

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 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.

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, subject to 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 i.e Itolizumab is also lesser than comparable drugs which are part of the “Investigational Therapies” indicated in the Clinical Management Protocol for COVID-19 of the Ministry of Health and Family Welfare.

Aditya Raj
Writer & Co-founder of InfotOnline.

More articles

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Must Read

“No new video coming till next year” says Carryminati

India's biggest YouTuber and streamer Carryminati has revealed that his video plans for December have been ruined due to some issues. The 21 year...

Wonder Woman 1984 release date in India in theatres revealed

The Gal Gadot starrer Wonder Woman 1984 release date in India in theatres has been revealed. This DC superhero movie will arrive in cinemas...

What to watch on December 4? Tenet, Suraj Pe Mangal Bhari or something else

As the last month of 2020 is finally here, lots of new movies and series are releasing on every platform possible this weekend. So,...

SRK delayed Emirates flight for Yo Yo Honey Singh, reveals the rap singer

The banter between King Of Bollywood, Shah Rukh Khan and Yo Yo Honey Singh has been witnessed in many live events, but in a...