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India and South Korea approve Gilead's remdesivir for emergency use against COVID-19

Image credit: Ulrich Perrey

India and South Korea have moved to follow in the footsteps of the US in approving Gilead’s antiviral therapy remdesivir for emergency use in a bid to fight the ongoing COVID-19 pandemic.

India’s Central Drugs Standard Control Organisation (CDSCO) has approved five different doses of the therapy for the treatment of hospitalised adult patients and children with “severe” manifestations of the disease.

Five-day remdesivir regimen shows promising clinical benefit in COVID-19 patients, Phase 3 data shows

Image credit: David Paul Morris/Bloomberg

Gilead has unveiled eagerly anticipated new Phase 3 data on the addition of its antiviral therapy remdesivir to standard of care (SoC) generated greater clinical benefit than SoC alone in moderately ill COVID-19 patients, specifically those with evidence of pneumonia without reduced oxygen levels.

The new data comes around a month following the release of previous findings from the SIMPLE study which previously compared five-day and 10-day regimens

Gilead's magrolimab shows promising responses in untreated myelodysplastic syndrome and acute myeloid leukaemia at ASCO 2020

Gilead took the opportunity at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting to unveil new Phase 1b data on the combination of its investigational anti-CD47 monoclonal antibody magrolimab with azacitidine, showing positive responses in treatment-naïve myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) patients.

Sixty-eight trial participants had received the drug combo by the time of data cut-off; 39 had higher-risk MDS, while 29 were AML patients who were not eligible for intensive chemotherapy. Both groups were previously untreated.

First ever benefit-risk analysis is "favourable" for remdesivir as COVID-19 treatment

The UK-based Drug Safety Research Unit (DSRU) has reported its findings from the first ever systematic benefit-risk analysis of Gilead’s remdesivir, one of the leading hope in the treatment of COVID-19, noting that it found the drug to have a tentatively “favourable” profile.

The team at DRU evaluated public data in peer reviewed journals and some clinical data which has not yet been published in order to build a profile of the therapy which detailed “all possible benefits and risks for COVID-19 patients receiving remdesivir”.

Japan authorises exceptional approval of Gilead's remdesivir for severe COVID-19

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Remdesivir, perhaps the leading hope in the race against COVID-19, has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) under the brand name Veklury for the treatment of severe COVID-19, its license holder Gilead has announced.

The antiviral therapy has emerged as the most effective treatment available thus far against the virus amongst a dearth of alternatives, though the mostly-positive efficacy data accumulated so far has been the subject  of criticism due to small study sizes which have often lacked control arms or have not been peer-reviewed.

FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic.

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The search for a COVID-19 treatment has ramped up this week, with two new studies detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with coronavirus, while researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential drug to help alleviate symptoms of the virus.

Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients

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The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

Gilead said that it had been made aware of “positive data” emerging from a randomised, controlled trial sponsored by the National Institute of Allergy and Infectious Diseases’ (NIAID) – the first in the US to test a therapy for the novel coronavirus – in hospitalized patients with advanced COVID-19 and lung involvement, noting that the trial had met its primary endpoint.

Leading COVID-19 hope remdesivir fails to provide clinical benefit in first randomised trial

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

In the China-based trial of 237 participants, 158 were randomised to receive remdesivir, while 79 received placebo plus standard of care. It was found that remdesivir failed to reduce the amount of the virus present in the bloodstream, and patients treated with it did not show clinical improvement.

Gilead's remdesivir significantly reduces COVID-19 symptoms in rhesus monkeys in NIH trial

Image credit: J.M.Garg,,,_AP_W_IMG_5792.jpg

A study from the National Institutes of Health has shed more light on the efficacy of Gilead’s promising antiviral therapy remdesivir in the fight against COVID-19, showing that the drug was able to “significantly reduce” clinical disease and lung damage in rhesus macaque monkeys infected with the novel coronavirus SARS-CoV-2.

The study utilised the same dosing and treatment procedures as those applied to human patients hospitalised with COVID-19 in another large, multicentre study conducted by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

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