U.S. doctors and others in the scientific community are calling for the release of data that convinced health regulators to authorize emergency use of Gilead Sciences Inc's antiviral drug remdesivir to treat COVID-19, so they can direct limited supplies on the right patients.
Vanda Pharmaceuticals Inc Chief Executive Mihael Polymeropoulos on Wednesday published an open letter asking for a full download of the trial findings that led to emergency use authorization by the U.S. Food and Drug Administration. "What if the drug is best suited to people early in the infection cycle? If we give it to people with severe disease - out of natural compassion - we may have wasted the drug," the CEO told Reuters.
He said Vanda, which is developing an anti-inflammatory drug for COVID-19, is looking to "lend our expertise." The FDA approved emergency use of remdesivir on May 1 based on preliminary results from a National Institute of Allergy and Infectious Diseases (NIAID) trial showing that the drug cut hospital stays by 31%, or about four days, compared with a placebo.
No other details of the 1,063-patient trial have been released. The Institute said by email that a report on the trial will be published in a few weeks. Gilead has not said when. "We want to direct the drug to those most likely to benefit and least likely to be harmed," Dr. Helen Boucher, chief of infectious diseases at Tufts Medical Center in Boston, told Reuters.
There are no formally approved treatments for COVID-19 - the sometimes deadly illness caused by the novel coronavirus - and remdesivir is the first drug to show benefit in a large placebo-controlled trial. Hospitals say they are concerned about distribution of limited supplies and are establishing ethical guidelines to ration remdesivir, without having seen the full trial data.
Katherine Perez, a pharmacy specialist in infectious disease at Houston Methodist Hospital, said her institution was prioritizing patients based on the drug trial's enrollment protocol, but needed more data to make better informed treatment decisions. Gilead's trials close by the end of the month and the NIAID plans to study remdesivir in combination with an anti-inflammatory compound.