Gilead Sciences is expanding its supply of the antiviral drug Redcivir, which is available to new corona patients in U.S. hospitals this week. But Redciewe’s treatment of the new crown is still to be finally evaluated.
Drug prices can be as low as $1
Daniel O’Day, CEO of Gilead Sciences, said Sunday that Reddit will be able to make u.S. patients available in the first half of the week, and gilead has teamed up with the U.S. government to decide which cities will use the antiviral drug first.
The Redsiewe drug is available for use in patients with severe illness, and the United States defines severe conditions as oxygen saturation (SpO 2) of 94%, or the need for oxygen support, mechanical ventilation, and the acceptance of in vitro pulmonary membrane oxygenation (ECMO), as defined in severe patients. Ridsiewe must be intravenously.
It comes after Gilead announced that it would donate all 1.5 million doses of Redcyway to the U.S. government for a 10-day course of treatment that could support more than 140,000. The number of new crowns confirmed in the United States now exceeds 1.1 million, with more than 66,000 deaths.
Joseph Fortunak, a professor of chemistry and pharmaceutical sciences at Howard University in Washington, d.C., told First Business: “The research and development of the Redsiwe drug is very expensive, and Gilead is under a lot of pressure to make the drug price acceptable.” In this case, it would be wise for the company to announce the donation. But donations certainly won’t be indefinite. “
Professor Fortunak said Gilead said it had spent hundreds of millions of dollars on the development of the Redsiewe drug. But in the case of oxycoquinone, which has also been urgently authorized by the FDA, Redciwe has no cost advantage.
Earlier, Professor Fortunak et al published a study comparing the cost of producing drugs that reached more than 1 million courses, which cost only 8 cents per patient per day; the price of a drug per patient per patient could be as low as $1, but Gilead said the figure did not “accurately reflect” the large-scale cost of production.
No country in the world has approved the drug, except for the U.S. grant warrant for emergency use of Gilead’s Redsiewe drug. On Friday, Japan’s Ministry of Labour, Health and Welfare said it was ready to include Gilead’s Redsiewe drug in the fast-track approval process and was expected to make it available to local patients in Japan a week after Gilead submitted its application.
Katsunobu Kato, Japan’s minister of health and labour, said: “I understand that Gilead will submit rid of Ridsiwe’s application in Japan in the next few days, and I have given instructions to approve it within a week.” “
Currently, redsyweed drugs outside the U.S. are primarily used in clinical trials, sympathetic drugs, and expanded access. Daniel O’Day said on Sunday: “Redsiewe has been exported for clinical trials and compassionate drugs, and we have worked openly and transparently with the U.S. government to distribute them, but our drugs have not been restricted for export, and as a global u.S. company, we certainly serve other countries.” “
In Europe, China and elsewhere, however, there is no sign that the drug will be approved quickly. A first clinical study of Redciewe, published last week, found that Redsiewe had no effect on patients with severe illness and did not help reduce mortality.
“We expect 1.5 million doses of Redciewe to be enough to treat more than 250,000 patients,” Dr. Kunal Dhamesha, an analyst at Indian brokerage SBICAP, told First Business. Gilead is also working with other companies to expand production capacity. The drug may be available in Europe through other suppliers. But from the current clinical data on Redciewe, it is not as good as expected, it does not change the mortality rate, but shortens the course of the disease. “
The “trick” of pharmaceutical companies?
Although the U.S. interpreted Redsywe’s clinical results as “positive,” doctors now have reservations about Redcie’s efficacy. Professor Mark Hoofnagle, a resident at the University of Maryland, said publicly on Twitter: “I regret to believe that Redciewe may be worthless, and we are seeing the ‘tricks’ of some great pharmaceutical companies. “
Professor Hofnager gave a number of reasons, first of all, from the drug mechanism, he believes that antiviral drugs in respiratory diseases, mainly because antiviral drugs are to inhibit the replication of the virus, but when the patient shows symptoms, the carrier of the virus has been very high, causing damage to the human body, when the human body has activated the antiviral immune response, and then the use of antiviral drugs is not significant.
Professor Hofnager’s “trick” refers to the number of years in mid-April when the National Institutes of Health (NIH) Institute of Allergy and Infectious Diseases (NIAID) revised the clinical endpoint indicators of the Ridsywe control trial to remove the “death” indicator and only the duration of the visit.
“It’s like when the run doesn’t reach the finish line and you realize you can’t run to the finish line, and you declare your position to be the end.” Prof Hofnag said.
Professor Cao Bin, head of clinical trials in China and vice president of the China-Japan Friendship Hospital, also told First Financial: “The main difference between Chinese and American clinical trials is the difference between the end of the study, the u.S. NIH research endpoint indicators are too loose.” If they use our indicators, the estimates are also negative. “
Professor Cao also noted that THE NIH clinical trial had modified the endpoint indicator. He told First Financial: “The NIH in the United States initially used the same main endpoint indicators as we did, but then they quietly modified the endpoint, probably to make it easier to get positive results.” “