US health regulator approves first treatment for Covid-192 min read . Updated: 23 Oct 2020, 08:25 AM IST
- Remdesivir or Veklury is now the first and only approved Covid-19 treatment in the United States
- Veklury is approved for people at least 12 years old and weighing at least 40 kilograms
Washington: The United States Food and Drug Administration (FDA) has approved Remdesivir for the treatment of coronavirus. Remdesivir or Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. According to the press release by the company, previously authorised by the FDA for only emergency use to treat COVID-19 patients, Veklury or Remdesivir is now the first and only approved COVID-19 treatment in the United States.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency," said FDA Commissioner Stephen M. Hahn, M.D.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks."
"This approval is based on three randomized controlled trials including the recently published, final results of the National Institute of Allergy and Infectious Diseases' (NIAID) double blind, placebo-controlled Phase 3 ACTT-1 trial, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with COVID-19. Based on the strength of these data, Veklury has become a standard of care for the treatment of COVID-19 in hospitalized patients," Gilead Sciences, Inc said.
Veklury is approved for people at least 12 years old and weighing at least 40 kilograms who need hospitalization for their coronavirus infection. For patients younger than 12, the FDA will still allow the drug's use in certain cases under its previous emergency authorization.
Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the US National Institutes of Health.
Possible side effects of Veklury include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.
According to the latest update by the Johns Hopkins University, globally 41,536,126 people have tested positive for coronavirus and 1,134,981 deaths have been reported so far.