| Pune |
Published: July 14, 2020 12:08:03 pm
There is a need for life-saving drugs until a vaccine for Covid-19 is developed, according to Kiran Mazumdar Shaw, executive chairperson of Biocon Ltd. Even if a vaccine is developed by the end of the year or next year, there is no guarantee that there will be no reinfections, Shaw said at a virtual press conference on Monday.
There is a need to be in a state of preparedness and Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe Covid-19 complications, she said.
Shaw presented key insights into the results of the pivotal study that demonstrated that its novel biologic therapy, Itolizumab, significantly reduced mortality in moderate to severe ARDS (acute respiratory distress syndrome) patients hospitalised with Covid-19 in India.
This led to the Drug Controller General of India (DCGI) approving the novel biologic therapy for restricted emergency use in India and allowing the firm to market Itolizumab (ALZUMAb) injection 25mg/5 ml solution for the treatment of cytokine release syndrome (CRS) in Covid-19 patients with moderate to severe acute respiratory distress syndrome.
Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as ALZUMAb for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to Covid-19. Each vial costs Rs 7,950 and the total cost of four vials is estimated at Rs 32,000.
While Shaw said Biocon is ramping up capacity to make the drug available in the country and globally, she also gave an insight into the development of the drug, its safety profile and data from clinical trials across four hospitals in Mumbai and New Delhi that showed statistically significant results.
Twenty people who were trial subjects were given the drug along with supportive care, while 10 others were only given supportive care. According to Dr Sandeep Athalye, chief medical officer of Biocon Biologics, 20 patients who were on Itolizumab recovered while three of the 10 patients who did not receive the drug died.
“The regulatory process is extremely robust. The kind of scientific discussions on this trial was of a very high order. This is an emergency situation and hence the sample size of patients involved in the clinical trial was small,” Shaw said while addressing queries. She, however, stressed that barring the trial data, many doctors and investigators had decided to use ALZUMAb to try and save more patients. “More than 150 patients have benefited from this drug across Solapur, Nagpur, Baroda and Delhi,” said Shaw.
Itolizumab, when administered to patients with moderate to severe ARDS due to COVID-19, effectively controlled hyper-activation of the immune system in response to the SARS-CoV-2 virus and prevented morbidity and mortality related to the ‘cytokine storm’. Older patients and those with co-morbidities like diabetes and hypertension, who were treated with Itolizumab, recovered well. The clinical trial showed that Itolizumab is best administered in the pulmonary phase of the Covid-19 infection when the cytokine build-up is starting, and the patient is experiencing shortness of breath and exhibiting abnormal chest images. It prevents progression to the hyperinflammation phase (cytokine storm) and other complications such as coagulation and organ failure, said Dr Athalye.
“The trick is to give the drug before the cytokine storm starts,” said Dr Rosemarie D’ Souza, professor of medicine, Medical Intensive Unit at B Y L Nair Hospital , Mumbai , which was involved in the clinical trial. The timing of administering the drug is important, reiterated Dr Vishal Gore, physician at Solapur’s CNS Hospital.
Dr Shashank Joshi, dean of Indian College of Physicians, who is an active member of the state COVID task force, said that they have been looking at several options for better treatment of Covid-19. “We do not have a cure but we have a novel option to save lives that can help bring down the mortality to less than 1 per cent,” said Dr Joshi.
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