India’s National Task Force rejects Biocon’s itolizumab for COVID-19

pharmafile | July 27, 2020 | News story | Sales and Marketing Biocon, COVID-19, India, Itolizumab 

Biocon was hit with bad news over the weekend as the National Task Force for COVID-19 in its home country of India decided not to back its anti-inflammatory drug itolizumab for the treating novel coronavirus infection.

The blow comes just two weeks after the therapy secured approval from the Drug Controller General of India for the treatment of COVID-19 patients with moderate to severe acute respiratory distress.

However, this decision drew criticism for awarding approval based on clinical data from a Phase 2 trial of just 30 patients.

The National Taskforce echoed these concerns, labelling the data as too “inconclusive” to recommend the drug for use. A spokesperson for the taskforce told The New Indian Express: “There was a long discussion on itolizumab but most members felt that there is no substantial evidence yet to include it in the national COVID-19 clinical management guidelines,”

Biocon has disputed concerns around the data, with a company spokesperson arguing that “nearly 1,000 patients have used the drug across the country with good outcome data.”

The company also said that it plans to sumbit further data in order to secure approval. “We have already announced that we have planned for a 200-patient pan-India Phase 4 trial to be conducted across 10-15 hospitals,” the spokesperson said. “The study protocol has been submitted to the DCGI and we will commence the trial soon.”

Matt Fellows

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