Gilead developing inhaled remdesivir usable outside of hospitals

Henrietta Brewer
June 2, 2020

"The approval process for remdesivir was accelerated by invoking special provisions under the New Drug and Clinical Trial Rules, 2019, which provides for waiver of clinical trials in special circumstances", the source said.

Moderately ill Covid-19 patients who received a five-day course of remdesivir were more likely to have clinical improvement after 11 days compared to those who received traditional standard of care alone, Gilead said.

The approval comes a day after the United States drugmaker reported that remdesivir showed modest benefit in patients with moderate COVID-19 given a five-day course, while those who received it for 10 days in the study did not fare as well. Gilead Sciences issued a statement on Remdesivir Clinical Data on Monday, saying, "With the latest data announced today, we now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures". The Indian Council of Medical Research had earlier said anti-viral medication remdesivir, which was used during the Ebola outbreak, may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of Covid-19 is a part of the WHO's "Solidarity Trial". However, while patients who received a 10-day course of the drug improved, the results were not statistically significant, suggesting just five days of treatment may be enough to help patients recover.

In India, Gilead has given voluntary licence for production of remdesivir to Cipla, Jubilant Life Sciences, Hetero Drugs and Mylan under a royalty-free arrangement till an alternative drug is found or until the World Health Organization removes the designation of "Public Health Emergency of International Concern" for the covid-19 pandemic.

Gilead said that within 11 days, 134 of the 191 patients given a five-course of remdesivir showed at least two points of improvement on the tracking scale, and no one died. A second phase of the study added up to 1,000 additional patients with moderate manifestations, and the results will be available in the coming months.

The US Food and Drug Administration has not approved any treatment for Covid-19 - but in early May, the FDA issued an emergency use authorization for remdesivir for use as a treatment for the sickest hospitalized Covid-19 patients. The emergency approval followed early results from a large, placebo-controlled study run by the USA government that showed patients getting remdesivir recovered faster than those who got a placebo.

Gilead says they plan to submit these results to a peer-reviewed journal in the upcoming weeks.

Gilead's most recent study also included a look at adverse reactions among patients given the drug.

In the new trial, Gilead said there were no new safety risks identified across either treatment group.

Now, given the spike in COVID-19 cases and the lack of a proven therapy, Dr. VG Somani, the Drugs Controller General of India, has approved Remdesivir for "restricted emergency use". "The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care".

Bailey Aldridge is a reporter covering real-time news in North and SC.

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