Health Ministry's guide for Covid-19 treatment drops itolizumab drug

FAQs for clinical management prepared by AIIMS and MoHFW says evidence for Favipiravir is weak

Despite the launches of many favipiravir brands, a Health Ministry document on clinical management of Covid-19 patients in ICUs notes that the evidence in favour of the drug is 'weak'. Moreover, the document does not mention the use of itolizumab, a Biocon drug that was granted an emergency use authorisation from the regulator for Covid-19 patients in July.

Earlier, the National Task Force for Covid-19 in India had not included Biocon's drug in its clinical management protocols for treating Covid-19. The drug had received a nod from the Drug Controller General of India to treat cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) patients who had Covid-19. The emergency use authorisation was based on data from a 30-patient clinical trial. Biocon is working to provide more data on the drug and a 200-patient trial is planned.

The new clinical management protocol for eICUs prepared as FAQs by the All India Institute of Medical Sciences (AIIMS), New Delhi and released by the Health Ministry on Wednesday too, did not mention any use of itolizumab.

In order to build capacities of ICU doctors in the clinical management of critical patients, AIIMS has started e-ICUs twice a week through tele or video consultation sessions with domain experts for doctors manning ICUs in state hospitals. Since July, around 17 such sessions have been held with participation from 204 institutions. AIIMS and the health ministry have developed FAQs to help doctors with clinical management.

The document, which touched upon several areas of disease management, including depression in patients, noted that the evidence is "weak for the use of favipiravir and is currently not recommended in national guidelines". It added that studies have used favipiravir mainly in mild or asymptomatic Covid-19, claiming to prevent progression. However, this cohort recovers with just supportive care and monitoring and usually requires no specific therapy, AIIMS and health ministry noted.

Already, several brands of generic favipiravir are available in India with the country's largest drug maker Sun Pharmaceuticals pricing it as low as Rs 35 per tablet. Dr Reddy's Laboratories has also launched the innovator brand Avigan for Rs 99 per tablet.

A pharma player that has launched the drug in the market said, "The AIIMS and health ministry document is aimed at describing clinical management for critical patients and favipiravir is not useful there. It is used to treat mild patients and there are several global studies that show it." He added that the company expects that demand for the drug will continue as it can be taken orally and by patients who are in home-care.