Remdesivir, an experimental anti-viral drug that was initially developed by Gilead Sciences to work against Ebola, is being tested under multiple trials for its potential in COVID-19 treatments.
The company is now planning to boost production and expand the global supply of the drug - even as evidence for the drug’s efficiency remains conflicted so far and more concrete results are awaited.
According to a statement issued on 6 May, Gilead is in discussions with some of the world’s leading chemical and pharmaceutical manufacturing companies about their ability, under voluntary licenses, to produce remdesivir for Europe, Asia and developing countries through at least 2022.
Negotiations are also underway with several generic drugmakers in India and Pakistan for long-term voluntary licenses for making the drug.
Meanwhile, the Food and Drug Administration (FDA) in the United States approved the medicine for emergency use against COVID-19, President Donald Trump announced at the white house on 1 May.
Gilead will now be providing the appropriate technology transfers to facilitate this global production, and is also in ‘active discussions with the Medicines Patent Pool’, which the company has partnered with for many years, to license remdesivir for developing countries.
The statement added, “To further facilitate access in developing countries during this acute health crisis, Gilead is in advanced discussions with UNICEF to utilize their extensive experience providing medicines to low- and middleincome countries during emergency and humanitarian crises to deliver remdesivir using its well-established distribution networks.”
Producing the drug requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities with limited global capacity.
Conflicting Evidence on Remdesivir Efficacy for COVID-19
FIT had earlier reported on studies that had found conflicting evidence for the medicine’s use in COVID-19 patients.
Promising results have been brought to the world’s attention, with Dr Anthony Fauci, a top US health advisor and director at the US National Institute of Allergy and Infectious Diseases (NIAID), claiming that the drug could possibly have a ‘clear-cut’ effect in fighting the novel coronavirus.
On the other hand, a Chinese trial reported in The Lancet found that the drug may not be as efficient in the treatment of patients with the disease.
In conversation with FIT, Dr SP Kalantri, director professor of Medicine at MGIMS and Medical Superintendent of Kasturba Hospital, had explained, “There’s a starking difference between the Lancet study and the US trial, even though the results in the former could have been impacted by the half-way enrollment mark achieved. The researchers rightfully concluded themselves that they could have missed detecting the differences between the two groups, or even any possible harms that the drug may have caused, because of an inadequate number of patients studied.”
“We need more data and more follow-up more numbers to be able to have more confidence. We need to curb our excitement, think rationally, examine critically, and then act,” he says.