‘Things Are Moving So Quickly’: Gilead Expands Drug Trials For Promising Antiviral That May Treat COVID-19
There are currently no approved treatments for illnesses caused by coronaviruses, including the new one, known as COVID-19. Meanwhile, top FDA officials warn that potential treatments, like Gilead's drug remdesivir, are going to come long before vaccines make it to market. Meanwhile, concerns about the drug supply into the United States heat up.
Reuters:
Gilead Starts Two Late-Stage Studies To Test Drug For Coronavirus
Gilead Sciences Inc said on Wednesday it has started two late-stage studies to test its drug in patients with severe and moderate cases of the illness caused by the coronavirus, sending its shares up 4% in extended trading. Beginning March, the studies will test the experimental antiviral drug, remdesivir, among nearly 1,000 patients at medical centers across Asian countries, as well as in other nations with high numbers of diagnosed cases, the company said. (2/26)
The New York Times:
Gilead To Expand Coronavirus Drug Trials To Other Countries
Remdesivir is already being tested in Wuhan, China, the center of the epidemic, and the United States National Institutes of Health announced on Tuesday that the drug would also be studied in some of the patients who contracted the illness overseas and were now being treated in Nebraska. Results from the trials in Wuhan are expected in April, the company said. The drug is still experimental, not yet approved to treat any disease. There are no approved treatments for illnesses caused by coronaviruses, including the new one, known as Covid-19. Studies of infected mice and monkeys have suggested that remdesivir can fight coronaviruses, and it appeared to cause few side effects when it was tested in patients with Ebola, although it did not work well against that virus. (Grady, 2/26)
The Wall Street Journal:
Gilead To Kick Off Its Own Studies Of Potential Coronavirus Drug
The studies, if successful, would help contribute to a larger dataset needed to win regulatory approval for the drug. It is too early to say if the two studies alone would be sufficient for regulators, said Diana Brainard, Gilead senior vice president for HIV and emerging viral infections. “Things are moving so quickly, it’s hard for us to gauge what the right approval package would look like in the U.S. or abroad,” Dr. Brainard said in an interview. “We’re in data-collection mode right now.” (Walker, 2/26)
Stat:
Coronavirus Vaccines Are Far Off, FDA Official Says, But Drugs To Treat Patients Could Come Sooner
New drugs to treat patients already infected with the novel coronavirus, which has sparked outbreaks across multiple continents, will emerge much more quickly than vaccines to prevent infection, a top Food and Drug Administration official said Wednesday. “The development of a vaccine is not going to prevent a pandemic here,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told STAT at the SVB Leerink Global Healthcare Conference, ahead of a keynote presentation there. And getting a vaccine ready for pivotal testing is going to take more than just a few months, he said. (Herper and Garde, 2/26)
The Washington Post:
Coronavirus Raises Fears Of U.S. Drug Supply Disruptions
The Food and Drug Administration is stepping up its monitoring of the drug supply for potential shortages, including 20 products that may be at risk due to the coronavirus outbreak that has shut down much of China and is raising concerns about the nation’s convoluted and highly outsourced pharmaceutical supply chain. The crisis highlights a growing vulnerability: Not only are many medications used in the United States manufactured overseas, but critical ingredients — and the chemicals used to make them — also are overwhelmingly made in China and other countries. (McGinley and Johnson, 2/26)
ABC News:
Coronavirus Could Lead To Drug Shortages In US
As the novel coronavirus paralyzes large chunks of China's economy, another possible result from the outbreak could strike closer to home for many Americans: shortages of lifesaving medication. The U.S. relies on China for electronics, clothes, toys and, increasingly, prescription drugs. About 90% of the active ingredients used by U.S. companies in drug manufacturing come from China, which has prompted politicians and public health experts to express concern over potential shortages of common generics. (Salzman, 2/27)
