New Delhi: An expert committee from the government of Narendra Modi has rejected the proposal by US drug company Eli Lilly to grant emergency authorization for its antibody therapy to treat Covid-19 patients in India.
Bamlanivimab, the monoclonal antibody therapy billed as the first Covid-19 treatment, is known for protecting people with mild disease from developing severe disease. It comes from the same family of drugs that were given to US President Donald Trump when he contracted the virus.
The U.S. Food and Drug Administration, the U.S. regulator of drugs, issued Emergency Use Authorization (EUA) in November for the therapy for the treatment of mild to moderate Covid-19 in adult and pediatric patients.
EUA is granted to non-approved medical products or non-approved applications of approved medical products in emergency situations such as pandemic.
Although the safety and effectiveness of this investigational therapy is still being evaluated, in clinical trials, Bamlanivimab has been shown to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk of disease progression within 28 days of post-placebo. therapy. , The US FDA said as it announced the EUA.
In India, the Subject Expert Committee (SEC) advising the apex regulator, the Drug Controller General of India, on applications for approval for new drugs, vaccines, and clinical trials, has rejected the proposal that also asked for “ distance from the local clinical taste “.
“After extensive deliberation, with the data available, the committee is of the opinion that emergency use authorization cannot be recommended,” the SEC said at a November 26 meeting, the minutes of which were recently uploaded to the Central Drugs Standard Control website. . Organization (CDSCO). The CDSCO is the branch of the health ministry that regulates the quality of medicines and vaccines in the country.
Also read: Eli Lilly’s CEO says Covid will be ‘endemic’ even with vaccines: Q&A
Drug showed no efficacy, panel says
Eli Lilly had presented her proposal to grant permission to import and market a 700 milligram dose of the drug under “limited emergency use” for the treatment of mild to moderate Covid, according to SEC minutes. -19 with “distance from local clinical trial in the country”.
The company presented phase II outpatient data for mild to moderate cases. The panel noted that the therapy was tested in “all cases that were mild cases according to Indian guidelines.”
“The committee noted that a dose of 700 mg showed no efficacy in the primary endpoint and no significant change in any other endpoint, including hospitalization,” the minutes said.
“After extensive deliberation, with the available data, the committee is of the opinion that emergency authorization cannot be recommended,” said the committee.
What are Monoclonal Antibodies?
According to the US FDA, monoclonal antibodies are lab-made proteins that mimic the immune system’s ability to fight harmful antigens such as viruses. “Bamlanivimab is a monoclonal antibody that specifically targets the SARS-CoV-2 spike protein, designed to block virus attachment and entry into human cells.”
Experimental monoclonal antibody treatments are being touted as a “powerful part of the arsenal” that doctors use to treat the coronavirus. Anthony Fauci, America’s top infectious disease expert, called antibody-based drugs a bridge to a vaccine.
However, the FDA noted that the benefit of bamlanivimab treatment was not seen in hospitalized patients.
In fact, the US FDA said that “monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospital patients with COVID-19 who require high flow oxygen or mechanical ventilation.”
Also read: Eli Lilly will not resume the interrupted study with Covid antibodies because it is unlikely to help advanced cases
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