DCGI gives nod for restricted emergency use to Itolizumab

New Delhi, July 11, 2020: Itolizumab
(rDNA origin), a monoclonal
antibody which was
already approved for severe
chronic plaque psoriasis, has
now been granted Restricted
Emergency Use authorisation
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
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 hyperinflammation
in COVID-19
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 Wel-
DCGI gives nod for restricted
emergency use to Itolizumab
For moderate to severe COVID-19 patients

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