Japan will fast-track a review of Gilead Sciences Inc's antiviral drug remdesivir so that it can hopefully be approved for domestic COVID-19 patients a week after the USA firm's filing for such approval, the health minister said on Saturday.
The FDA acted after preliminary results from a government-sponsored study showed that Gilead Sciences's remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized Covid-19 patients.
The median recovery time was 11 days for patients in the remdesivir group versus 15 days for those in the placebo arm of the study.
Critical care specialists in India said it is too early to predict the impact of the the US FDA decision on emergency use authorisation on India's policy on the drug. The drug has delivered encouraging results on Covid patients in need of advanced care and helped quicken recovery.
The drug maker, which reported second-quarter earnings on Thursday, said it would work with worldwide partners to expand production of the potential Covid-19 treatment.
The FDA has not yet approved the drug.
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The ministry would aim for swift approval through special, highly-simplified procedures only available for drugs in urgent need that have already been approved in other countries. Experts said though the trial is significant as it is suggestive of reduction in symptomatic time, it can not be used as a standard treatment because of limited evidence.
In a statement, Gilead Sciences said that the EUA will facilitate broader use of Remdesivir for the treatment of hospitalised patients with severe infection.
"I can assure you that we're all focused on making sure that we make this accessible and affordable to patients around the globe", he said. While the company suggested this meant more patients could be treated with the drug, the lack of a control group rendered the results all but meaningless. However, patients with symptom duration of 10 days or less who received remdesivir had a numerically faster time to clinical improvement than those who received a placebo.
The authorization clears remdesivir for use for hospitalized adults and children with severe cases of COVID-19, such as those requiring supplemental oxygen or ventilation.
"There has been no other time like this in the history of the planet", Chief Executive Officer Daniel O'Day said on the call.
Gilead also warns of possible serious side-effects. When scientists found out that this medicine can be a potential human coronaviruses cure, Gilead Sciences immediately submitted it to the FDA to be clinically tested by the government. Experts also stressed that the emergency use is not the same as full approval.