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Covid drug Remdesivir gets USFDA nod

Our Bureau Mumbai | Updated on October 23, 2020 Published on October 23, 2020

Indian licensees’ royalty-free status to continue for now

The US Food and Drug Administration has approved Gilead Sciences’ anti-viral Remdesivir, making it the first treatment for Covid-19 to get the final go-ahead from the regulator.

The approval comes within days of the World Health Organization’s Solidarity trial findings that the drug made no difference to mortality.

Indian drugmakers including Hetero, Jubilant and Cipla have voluntary licensing agreements signed with Gilead to make and supply less-expensive versions of the injectable to 127 countries.

In its approval, the USFDA said Veklury (the Gilead brandname of remdesivir) was approved for use in adult and pediatric patients aged 12 and higher, weighing at least 40 kg for the treatment of Covid-19 requiring hospitalisation. “Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care”, it said.

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This approval does not include the entire population, which had been authorised to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020, the regulator clarified. The approval and revised EUA were given to Gilead Sciences Inc.

Responding to whether the final USFDA approval would change anything on the ground for the licensee companies, a Gilead spokesperson said, “We have negotiated long-term voluntary licences with nine manufacturers to supply generic remdesivir to 127 low- and middle-income countries. The licences are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding Covid-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier.”

Access to children

 In order to ensure continued access to the paediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorise the drug’s use for treatment of suspected or laboratory-confirmed Covid-19 in hospitalised paediatric patients weighing 3.5-40 kg or hospitalised paediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this paediatric patient population are ongoing, the USFDA said.

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FDA Commissioner Stephen M Hahn said the approval was supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.

The approval of Veklury was supported by the agency’s analysis of data from three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe Covid-19, the FDA said.

 

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Published on October 23, 2020
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