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Biocon Ltd will provide the National Task Force for covid-19 a large sample of real world data on its novel biological drug itolizumab for treatment of cytokine storm in severe patients after its initial 30-patient trial failed to convince the committee members to include the drug in its clinical management guidelines.

“The National COVID-19 Task Force needs to see more evidence and we will provide them a large sample of real-world data to enable the committee to reconsider its decision on inclusion of Itolizumab in the clinical management protocol," the company said in a statement.

Biocon said that the drug has been used on nearly 1,000 patients across the country and generated good outcome data, and the company also announced plans to conduct a 200-patient, pan-India Phase 4 trial across 10-15 hospitals.

The study protocol has been submitted to the DCGI and we will commence the trial soon, the company said.

“The results from the Phase 4 will create a larger body of evidence for efficacy of Itolizumab in covid-19 complications." Biocon said.

A phase 4 trial, also known as a post-marketing surveillance trial, of a drug is conducted after getting approval from the regulator Drug Controller General of India V.G. Somani for use against a particular disease and is used to measure the safety and efficacy of the drug.

Biocon’s itolizumab was given the emergency use authorisation based on a 30-patient study in which all 20 patients who were given the drug recovered, while three of the 10 who weren’t given the drug died. Apart from the 20 patients, another 150 patients were also given the drug on compassionate grounds through ‘off-label use’—the term refers to the use of a drug in an emergency for a disease or medical condition that it is not approved to treat.

However, the National Task Force did not approve inclusion of the drug in the clinical management protocol for the drug on Sunday due to lack of data, a government source in the know said.

“The task force felt that there was not enough data to support its inclusion in the protocol. The company is saying it will provide more data. That is awaited now," the source said.

Approval for the drug based on data from just 30 patients attracted criticism for the company and the regulator.

Biocon has countered those criticisms by saying that the 30-patient study was conducted for extension of the drug’s use for cytokine storms and that it has a has a seven-year proven track record of safety. The drug received DCGI approval in 2013 for treatment of psoriasis, an autoimmune condition, after a three-phase trial.

The company also said that the Cuban regulator has also authorized use of itolizumab in cases of COVID-19 after evaluation of data submitted by the company's Cuban partner, Centre of Molecular Immunology, and various institutions of the Cuban health system.

The authorization was also based on the results from the controlled trial carried out by Biocon in India, which confirmed the data obtained in Cuba on itolizumab's potential to reduce mortality.

Biocon’s US-based partner, Equilllium, is also planning to conduct a global randomized controlled clinical trial of Itolizumab in COVID-19 patients for which it will file a US investigational new drug application (IND) soon, Biocon said.

Roche’s tocilizumab is another drug used for treatment of cytokine storms in severe covid-19 patients but has not been given an EUA in India despite use of the drug being backed by various retrospective, observational studies. Several prospective clinical trials for the drug are also being conducted, included 379-patient trial by Roche subsidiary Genetech Inc, according to the US government’s global clinical trial registry.

The drug, marketed in India by Cipla Ltd, is included in the clinical management protocol for ‘off-label use’.

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