Gilead Is Testing an Inhalable Form of Intravenous Remdesivir

Grant Boone
July 1, 2020

The EMA cited a clinical trial of more than 1,000 patients hospitalized with COVID-19.

In the letter, O'Day pointed at previous studies showing remdesivir's potential in treating COVID-19 patients.

The therapy was the primary to point out enchancment in trials on COVID-19 sufferers and has gained approval for emergency use in severely sick sufferers within the United States and South Korea, and acquired full approval in Japan.

Drug Controller General of India (DCGI) has given the nod to the generic versions made by Cipla and Hetero for restricted emergency use in severe COVID cases.

The drug will be accessible only via hospitals and government, and not through retail, said Hetero Group of Companies MD Vamsi Krishna Bandi.

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Besides Hetero and Cipla, three other firms BDR, Jubilant, Mylan and DR Reddy's Labs have also applied to CDSCO for permission to manufacture and market the drug in India and are still awaiting permission. In the NIAID study, remdesivir shortened recovery time by an average of four days, and in the SIMPLE study of moderately ill patients (those in hospital but not requiring oxygen), individuals on a five-day course of remdesivir had better clinical outcomes than those receiving standard of care, he said.

On Monday June 22, Gilead Sciences announced it is preparing to kick off a trial testing an inhalable version of the investigational COVID-19 drug remdesivir. It is yet to be priced in the United States.

"This type of approval allows the Agency to recommend a medicine for marketing authorization with less complete data than normally expected, if the benefit of a medicine's immediate availability to patients outweighs the risk inherent to the fact that not all the data are yet available", the EMA continued.

However, the drug is still not licensed or approved anywhere in the world, according to an earlier statement by Gilead.

Research on the drug was first started by Gilead in 2009 with research programs for the treatment of hepatitis C (HCV) and respiratory syncytial virus (RSV) and its antiviral profiling was done in 2013 and early 2014-that suggested its broader antiviral potential. The drug previously failed trials as an Ebola treatment.

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