FDA might grant emergency approval of remdesivir for COVID-19

Multiple studies have yielded mixed results on the effectiveness of Gilead's drug, remdesivir, for the treatment of Covid-19, but a new study announced by the company suggests it could be effective for some patients. File Photo by Terry Schmitt/UPI

April 30 (UPI) — The U.S. Food and Drug Administration might grant emergency approval for the antiviral drug remdesivir as a treatment for COVID-19 following new clinical trial results that suggest the drug could help some patients.

The New York Times and CNBC on Wednesday reported the FDA was working with manufacturer Gilead Sciences to make remdesivir available to patients who have COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.

Gilead earlier Wednesday announced preliminary results of a trial with COVID-19 patients, which suggests that at least 50 percent of those treated with a five-day regimen showed improvement. More than half of those enrolled in the study were discharged from the hospital within two weeks of receiving the drug.

The new trial results on remdesivir, a drug originally developed to treat Ebola, appear to contradict those of a trial the World Health Organization posted in error last week. The study was published Wednesday by The Lancet.

While that study found the drug was safe and adequately tolerated, researchers said it showed minimal benefits over a placebo. The length of time to clinical improvement and risk for death were the same, though remdesivir appeared to shorten the duration of mechanical ventilation required for patients.

Gilead’s announcement of results from the large SIMPLE trials, which will eventually enroll 6,000 COVID-19 patients who are on mechanical ventilation at 180 hospitals worldwide, included 397 hospitalized patients with severe illness from the coronavirus.

Participants received 200 milligrams of remdesivir on the first day, followed by 100 mg. daily for five or 10 days, with all doses delivered intravenously.

The time to clinical improvement for 50 percent of the patients was 10 days in the five-day treatment group and 11 days in the 10-day treatment group. At day 14, 65 percent of the participants in the five-day treatment group and 54 percent in the 10-day treatment group achieved clinical recovery.

Patients who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms, according to Gilead.

By Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late, the company said.

“These data are encouraging as they indicate that patients who received a shorter, five-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” study co-author Dr. Aruna Subramanian said in a statement released by the company.

“While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective,” said Subramanian, who is chief of Immunocompromised Host Infectious Diseases at Stanford University School of Medicine.

Gilead on Wednesday also noted that another trial by the National Institute of Allergy and Infectious Diseases met its main efficacy goal. However, it did not elaborate.


Please enter your comment!
Please enter your name here