COVID-19 Disease Treatment Closes Down Access
Gilead infusion-delivered remdesivir remains available under FDA authorization
Clinical studies of an experimental coronavirus disease treatment will soon wind down, closing off a path often used by patients to access the antiviral medication remdesivir, according to U.S. researchers involved in the studies.
Remdesivir will remain available on a compassionate use basis for pregnant women or children under the age of 18, but most COVID-19 patients will soon have access only through special authorization, confirmed Reuters of May 15, 2020.
Gilead Sciences Inc’s infusion-delivered remdesivir was awarded an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) on May 1, 2020, but hospitals are concerned about access.
Gilead’s studies - one in patients with severe COVID-19 and the other in moderate disease - have enrolled around 8,000 subjects, according to FDA statistics.
Interest in Gilead’s drug has been very intense given some promising early data.
Preliminary results from a trial conducted by the U.S. National Institutes of Health (NIH) showed that remdesivir cut hospital stays by 31 percent compared to a placebo.
The NIH is now studying remdesivir alone compared to remdesivir in combination with Olumiant, an anti-inflammatory drug approved for rheumatoid arthritis.
This study published results on April 29, 2020, that indicate patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course.
To expand the worldwide access to remdesivir, Gilead announced on May 12, 2020, agreements to allow the companies – Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences, and Mylan – to manufacture remdesivir for distribution in 127 countries.
The selected countries consist of low-income and lower-middle-income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access around the world.
Furthermore, on May 13, 2020, Diana Brainard, Senior Vice President, and Virology Therapeutic Area Head, said in a media statement ‘Based in part on this data, the medicine was also approved last week by the Japanese Ministry of Health, Labour and Welfare for patients with severe COVID-19 under an exceptional approval pathway.’
‘Other than in Japan, remdesivir is an investigational drug that has not been approved by any regulatory authority and has not been demonstrated to be safe or effective for any use.’
Previously, the US Department of Health and Human Services said Gilead had committed to supply U.S. hospitals with around 600,000 vials of remdesivir, which is enough to treat at least 78,000 patients.
Precision Vaccinations publishes COVID-19 treatment news.