Egypt’s drugmaker Eva Pharma announced on Sunday it had reached a “historic” deal with Gilead Sciences Inc to become the licensed manufacturer of the US company’s antiviral treatment Remdesivir for coronavirus in 127 countries.
Remdesivir is the first treatment shown to be effective against the novel Covid-19 in human trials.
The drug has recently been approved for emergency use to treat hospitalized patients in a number of countries including the US and the UK.
“The voluntary license agreement provides Eva Pharma with Gilead’s technology as well as manufacturing specifications and methods in order to boost the timeline of the production of Remdesivir as soon as possible,”
Whats is Remdesivir ?
The broad-spectrum antiviral agent remdesivir (GS-5734; Gilead Sciences, Inc) is a nucleotide analog prodrug. On May 1, 2020, The US FDA issued EUA of remdesivir to allow emergency use of the agent for severe COVID-19 (confirmed or suspected) in hospitalized adults and children.
Remdesivir was studied in clinical trials for Ebola virus infections but showed limited benefit. Remdesivir has been shown to inhibit replication of other human coronaviruses associated with high morbidity in tissue cultures, including severe acute respiratory syndrome coronavirus (SARS-CoV) in 2003 and Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012.
Effectiveness against Coronavirus:
As of April 2020, remdesivir was viewed as the most promising treatment for COVID-19,and was included among four treatments under evaluation in the international Solidarity trial and European Discovery trial.
The FDA stated on 1 May 2020, that it is “reasonable to believe” that known and potential benefits of remdesivir outweigh its known and potential risks, in some specific populations hospitalized with severe COVID‑19. As of May 2020, there was no good evidence that remdesivir reduced mortality in people with COVID-19.
In January 2020, Gilead began laboratory testing of remdesivir against SARS-CoV-2, stating that remdesivir had been shown to be active against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) in animal models. On 21 January 2020, the Wuhan Institute of Virology applied for a Chinese “use patent”, for treating COVID‑19.
In a trial in China over February-March 2020, remdesivir was not effective in reducing the time for improvement from COVID‑19 or deaths, and caused various adverse effects, requiring the investigators to terminate the trial.
On 18 March 2020, the World Health Organization (WHO) announced the launch of a trial that would include one group treated with remdesivir. Other clinical trials are underway or planned.
Preliminary data from an international multi-center, placebo controlled double-blind randomized controlled trial carried out by the U.S. National Institutes of Health, suggests that remdesivir is effective in reducing the recovery time from 15 to 11 days in people hospitalized with COVID‑19.
On 29 April 2020, based on results of the ACTT trial, the National Institute of Allergy and Infectious Diseases (NIAID) announced that remdesivir was better than a placebo in reducing time to recovery for people hospitalized with advanced COVID‑19 and lung involvement.
The study appeared on The New England Journal of Medicine website almost a month later on 22 May 2020, and despite generally positive results, the study concluded that “given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”
A previous Chinese study published in The Lancet did not show significant benefits or drawbacks of using remdesivir, concluding that further research is required to understand the effectiveness of the drug.
This article was criticised as underpowered due to a lack of significant results as well as the fact that the study was ended prematurely. Based on the results of its study, the NIH stopped the ACTT trial and provided remdesivir to participants assigned to received placebo.
In April 2020, the European Medicines Agency (EMA) started a ‘rolling review’ of data on the use of remdesivir in COVID‑19. It completed the review in May 2020.
In May 2020, a number of companies in India and Pakistan have been given the right to make the medication.
In June 2020, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started evaluating remdesivir for a conditional marketing authorization after receiving an application from Gilead Sciences.