New Delhi: An expert committee of the Narendra Modi government has rejected American drugmaker Eli Lilly’s proposal to grant emergency authorisation to its antibody therapy for treating Covid-19 patients in India.
Bamlanivimab, the monoclonal antibody therapy labelled as the first Covid-19 treatment, is known to protect people with mild illness from developing a severe form of the disease. It comes from the same family of medication that was given to US President Donald Trump when he contracted the virus.
The US Food and Drug Administration, the American drug regulator, granted Emergency Use Authorisation (EUA) to the therapy in November for the treatment of mild-to-moderate Covid-19 in adult and paediatric patients.
EUA is granted to unapproved medical products or unapproved uses of approved medical products in emergency conditions such as pandemic.
“While the safety and effectiveness of this investigational therapy continues to be evaluated, Bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the US FDA said while announcing the EUA.
However, in India, the Subject Expert Committee (SEC) that advises the apex regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials has rejected the proposal that also asked for “waiver of the local clinical trials”.
“After detailed deliberation, with the available data, the committee is of the opinion that emergency use authorization cannot be recommended,” the SEC said at a meeting on 26 November, minutes of which were uploaded recently on the website of the Central Drugs Standard Control Organisation (CDSCO). The CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in the country.
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Drug showed no efficacy, says panel
Eli Lilly, according to the SEC minutes, had presented its proposal for grant of permission to import and market 700 milligram dose of the drug under “restricted emergency use” for treatment of mild-to-moderate Covid-19 with “waiver of local clinical trial in the country”.
The firm presented Phase II out-patient data from mild-to-moderate cases. The panel noted that the therapy was tested in “all the cases which were mild cases according to the Indian guidelines”.
“The committee noted that 700 mg dose was not showing efficacy in the primary end point and any significant change in any other endpoint including hospitalization,” the minutes said.
“After detailed deliberation, with the available data, the committee is of the opinion that emergency use authorization cannot be recommended,” it said.
What are monoclonal antibodies?
According to the US FDA, monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. “Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.”
Experimental monoclonal antibody treatments are touted as a “powerful component of the arsenal” that doctors use to treat the coronavirus. Anthony Fauci, the top US infectious-disease expert, has referred to antibody-based medicines as a bridge to a vaccine.
However, FDA has noted that the benefit of bamlanivimab treatment has not been seen in hospitalised patients.
In fact, the US FDA said “monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation”.
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