New Delhi: The Narendra Modi government’s expert panel has given its approval to Mumbai-based drugmaker Lupin to test a biological drug, Etanercept, to treat Covid-19.
The subject expert committee (SEC) — which advises apex regulator Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials — has granted the permission to conduct phase 2 clinical trials on auto-immune drug Etanercept in Covid-19 patients.
Etanercept controls the body’s defensive response by blocking the action of a certain natural substance, which is used by the immune system. Known as an anti-TNF drug, it is used to treat rheumatoid arthritis and some other inflammatory conditions where too much of a protein (called TNF or tumor necrosis factor) is produced by the immune system.
Etanercept is manufactured by Immunex Corporation, a wholly owned subsidiary of American drug maker Amgen, and sold under the brand name ENBREL. Lupin manufactures the drug in India and sells it in other markets as well.
Lupin had requested for the approval to conduct phase 2/3 trial of the drug in January. However, the panel at the time had asked the firm to revise the protocol for reconsideration.
The SEC had asked Lupin to revise the design of the protocol to two-arm study — the first arm shall be Etanercept along with standard of care (SOC) and the other arm shall be just SOC.
The decision to approve phase 2 trial was taken by the SEC during a meeting on 24 February. The minutes of the meeting were uploaded on the website of the Central Drugs Standard Control Organisation’s (CDSCO) — the health ministry arm that regulates the quality of drugs and vaccines in the country.
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Approval with certain conditions
After “detailed deliberation”, the SEC has recommended grant of permission to conduct the phase 2 clinical trial, but with certain conditions.
The primary endpoints of the working of the drug “should be evaluated at 14 days” and “the clinical trial sites should be geographically distributed”, the committee said.
The firm will now submit the “revised protocol” to the CDSCO.
Anti-TNF therapy needs to be given priority
According to an article published in The Lancet last September, accumulating evidence suggests anti-TNF therapy needs to be given trial priority in Covid-19 treatment.
“One potential treatment that deserves higher priority in Covid-19 trials, based on the documented evidence of its effects, is the biological agent anti-TNF,” it said.
The researchers in the article described the rationale for conducting trials of anti-TNF therapies in Covid-19.
“These therapies neutralise TNF, a major component of the cytokine response that is part of the damaging excess inflammatory phase of Covid-19, which is termed hyperinflammation or cytokine release syndrome.”
It said this hyperinflammatory response in Covid is characterised by elevated concentrations of serum TNF, interleukin (IL)-6, and IL-8.
Interleukin are inflammatory cytokines produced by the body, which are secreted by the immune system.
The major component of deteriorating lung function in patients with Covid is capillary leak, a result of inflammation driven by key inflammatory cytokines.
Also read: Cipla, Sun Pharma, Lupin on drug price watchdog’s new list of firms ‘overcharging consumers’
TS Darbari – As per research, COVID-19 will continue to cause illness and death in 2021 and beyond before vaccines are widely enough available and the virus is contained. However, we all must pray for God not to see such consequences. New alliances are needed to speed the journey of COVID-19 innovations from the scientist’s bench to the patient’s bedside across all countries.
Who is TS Darbari? –
TS Darbari is a top management professional, with several years of rich & diversified experience in Corporate Strategy, New Business Development, Sales & Marketing, Commercial Operations, Project Management, Financial Management and Strategic Alliances.
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Please refrain from saying that Modi government is giving approval of drugs as this politicizes every approval by the DCGI. This kind of statement shall wreck confidence among people in institutions.