Two days after India's drug regulator approved itolizumab for restricted emergency use for treatment of COVID-19 patients, Biocon Chairperson Kiran Mazumdar Shaw on Monday addressed concerns over the small clinical trial involving only 30 persons based on which approvals were granted.
Drugs Controller General of India (DCGI) Dr V G Somani had approved the repurposing of itolizumab injection, which has been used to treat psoriasis – a skin disorder – for use in the treatment of COVID-19 patients. Biocon, a domestic biopharmaceutical company, has been manufacturing and marketing itolizumab for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under the brand name Alzumab.
Biocon conducted a randomised trial in four hospitals across Mumbai and New Delhi to study the efficacy and safety of itolizumab for patients with COVID-19 complications. 20 people who were the trial subjects were given the drug along with supportive care, while 10 others were only given supportive care. Biocon states that 20 patients were on itolizumab recovered, while three of the 10 patients who did not receive the drug died. Biocon Chairperson Kiran Mazumdar Shaw said in a virtual press conference the small clinical trial gave “a very, very strong statistically significant data that then allowed regulators to give us the restricted emergency approval.”
When asked whether 20 patients was statistically too small a number to draw any scientific conclusions on the success of the trial, and if DCGI’s approval was rushed, Kiran said, “This is an emergency situation; in an emergency the size of the trials is always small and that’s why it’s given restricted emergency approval. I want to mention emphatically that the regulatory process is extremely robust. The kind of scientific discussion we had was of a very high order.”
She also noted that as the drug was already approved for the treatment of psoriasis patients in 2013, so there was no need for a longer study to show its safety. “Here, since the safety was already known, we decided to do an efficacy study,” she noted.
DCGI has granted 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. A cytokine storm is an overreaction by a patient’s immune system to fight off an infection, causing high fevers, respiratory distress and lung damage.
Dr Hemant Thacker of Bhatia and Jaslok Hospital in Mumbai, which was one of the centres for the clinical trial said, “It’s a single dose to prevent the patient from getting on to the ventilator. This is a great drug which will form a pillar in treatment in cytokine storm prevention and in attenuation of cytokine,” he said at the press conference.
The use of the drug is subject to some conditions including requirement of informed consent of patients, a risk management plan, and usage only in hospital setup.
The cost of the therapy is around Rs 32,000 with each vial costing nearly Rs 8,000. According to Biocon, each patient needs four vials of itolizumab.
When questioned about the affordability of the drug, Kiran Mazumdar Shaw countered, “People must also ask how much does it costs the government or the private sector, or how much it costs for a private paying patient to stay in an ICU setting for a number of days. No one takes that into question. Doctors are saying you can discharge the patient much sooner (after treatment with itolizumab) and you are also saving lives. The cost of going on the ventilator is very high, and if this drug can prevent that... So, in relation to that, a cost of Rs 25,000 to 30,000 to save a life and reduce the number of days spent in an ICU is hugely beneficial and not at all expensive.”
(With PTI inputs)