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.
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