- Gilead Sciences published new data Friday on its antiviral drug remdesivir that shows it reduced the risk of death for severely sick coronavirus patients by 62% compared with standard care alone.
- Shares of Gilead rose almost 3% in premarket trading Friday on the news.
- Gilead said the findings must be further investigated in further trials.
Gilead Sciences announced new findings Friday that its antiviral drug remdesivir reduced the risk of death for severely sick coronavirus patients by 62% compared with standard care alone, saying more research is needed.
The company said its analysis also found that remdesivir treatment was associated with "significantly improved clinical recovery." The findings are being presented at the Virtual Covid-19 Conference as part of the 23rd International AIDS Conference, the company said.
Shares of Gilead rose more than 2% Friday on the news.
The company said it analyzed data from 312 patients enrolled in its phase three trial and compared it with that of 818 patients in "a real-world retrospective cohort" with similar characteristics and disease severity who received standard care alone during the same time period as the phase three trial.
That means the company compared patients in its late-stage trial with patients receiving care in a real-world context. Different conditions in the different subsets of patients could complicate the findings.
"While not as vigorous as a randomized controlled trial, this analysis importantly draws from a realworld setting and serves as an important adjunct to clinical trial data, adding to our collective understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic," Dr. Susan Olender, of Columbia University Irving Medical Center, said in a statement.
The findings show that 7.6% of patients treated with remdesivir died compared with 12.5% of patients in the analysis who did not receive remdesivir treatment. The analysis also found that 74.4% of patients who received treatment with remdesivir recovered by day 14 compared with 59% of patients who received standard care alone.
Gilead said its findings warrant more study in additional trials.
"We are working to broaden our understanding of the full utility of remdesivir," Gilead's Chief Medical Officer, Dr. Merdad Parsey, said in a statement. "To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir."
In late April, the National Institute of Allergy and Infectious Diseases released preliminary results from its own study of remdesivir that showed patients who took the drug usually recovered after 11 days, four days faster than those who didn't take it. However, the study did not find any statistically significant reduction in the risk of death among patients treated with remdesivir.
Gilead has previously released data from its own clinical trials of remdesivir that have also shown a hastened recovery time and a modest clinical benefit.
The NIAID findings led the Food and Drug Administration to issue an emergency use authorization for remdesivir, allowing doctors to use the drug on hospitalized Covid-19 patients. However, remdesivir has not undergone the same level of review as fully FDA-authorized drugs. There are still no FDA-authorized drugs to treat Covid-19.
Last week, the company announced the much-anticipated pricing for remdesivir, saying it would charge governments of developed countries $390 per vial. That comes to a price of $2,340 per patient, considering the company expects most patients to require six vials during their care.
However, Gilead said it would charge $520 per vial for U.S. private insurance companies. Gilead faced some backlash for charging a higher price in the United States, but the company defended itself, saying that's simply a factor of the U.S. health-care system.
Every drug in the U.S. has two list prices because of the country's health-care system, Gilead CEO Daniel O'Day said in an interview last week with CNBC's Meg Tirrell on "Squawk Box" after the announcement. He added that he stands by the pricing structure and that it will ensure access for those who need it.
The company has been donating doses to the U.S. government for distribution since it received emergency use authorization in May. The Department of Health and Human Services said last week that it has secured more than 500,000 treatment courses of the drug, which it will distribute to American hospitals through September. HHS said the drug will be distributed to hospitals based on burden of Covid-19 patients.
While remdesivir was the first drug that appeared to effectively treat Covid-19 patients in a clinical study, other therapeutics have shown signs of efficacy and could threaten to make remdesivir more obsolete. Researchers at Oxford University, for example, released results from their trial last month that showed dexamethasone, a cheap and widely available steroid, can cut the risk of death by a third for Covid-19 patients on ventilators, and by a fifth for those on supplemental oxygen.
— CNBC's Berkeley Lovelace Jr. contributed to this report.