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Friday, May 1 2020

Full Issue

A Reality Check On Remdesivir Results: This Isn't A Cure, Data Is Not Yet Public And Manufacturing Is Tricky

Politico looks at the reasons why people should remain cautious over the Gilead drug trial results conducted by NIH that show that remdesivir can help cut hospitalization time for coronavirus patients. Meanwhile, Gilead announced its ramping up production of the treatment. And old drugs may find new life in the race for a cure.

The nation鈥檚 top health officials say they鈥檙e rushing to make sure Americans can get widespread access to the experimental drug remdesivir after a study showed that it shortens the recovery time for some coronavirus patients. The push to give the drug the regulatory approval it needs for broader distribution comes a day after the government鈥檚 top infectious disease expert, Anthony Fauci, called the drug 鈥渁n important proof of concept鈥 and compared it to the discovery of the earliest HIV treatments in the 1980s. Investors sent U.S. stocks surging after the news was announced. (Brennan and Owermohle, 4/30)

Gilead Sciences Inc maker of the closely-watched experimental coronavirus drug remdesivir, on Thursday said it will work with international partners to expand production of the potential COVID-19 treatment. The company said it still expects to have more than one million remdesivir treatment courses manufactured by December, 鈥渨ith plans to be able to produce several million treatment courses in 2021.鈥 By the end of next month, Gilead said it expects to have manufactured enough of the drug to treat more than 140,000 patients, and it plans to donate that supply to hospitals. (Beasley, 4/30)

Gilead is talking with other drug-makers to help organize supply chains that can help get remdesivir to patients globally, Chief Financial Officer Andrew Dickinson said on a conference call with analysts to discuss first-quarter earnings. He cautioned, though, that some of the substances used to make remdesivir are scarce, and the company wants to be careful not to disrupt its own supply chain, which is the quickest route to get the drug to patients. 鈥淥ur primary focus is on providing access to patients around the world,鈥 said Mr. Dickinson. (Walker and Maidenberg, 4/30)

Gilead Sciences said Thursday that it can produce 鈥渟everal million鈥 rounds of its antiviral drug remdesivir next year to help patients fight the coronavirus. The company expects to produce more than 140,000 rounds of its 10-day treatment regimen by the end of May and anticipates it can make 1 million rounds by the end of this year. (Lovelace, 4/30)

Infectious disease specialist Dr. Simone Wildes shared her excitement on "The View" Thursday after a recent clinical trial showed promising early results for using the drug remdesivir against the coronavirus, calling it a "step in the right direction." Dr. Anthony Fauci, the country's top infectious disease expert and a member of the White House's coronavirus task force, announced the results of the experimental antiviral drug trial on Wednesday. Preliminary results from the randomized, placebo-controlled trial on 1,063 hospitalized patients showed that 31% of the patients who received remdesivir had a faster recovery time than those who received a placebo. The remdesivir group also saw an 8% mortality rate compared to an 11.6% mortality rate among the group on placebo. (Rosa, 4/30)

In the early 1950s, psychiatrists began treating schizophrenia with a new drug called chlorpromazine. Seven decades later, the drug is still used as an anti-psychotic. But now scientists have discovered that the drug, also known as Thorazine, can do something entirely different. It can stop the new coronavirus that causes Covid-19 from invading cells. Driven by the pandemic鈥檚 spread, research teams have been screening thousands of drugs to see if they have this unexpected potential to fight the coronavirus. (Zimmer, 4/30)

Scientists and drug companies searching for a coronavirus treatment have launched so many clinical trials that some now fear they will run out of patients to enroll, trial sites or personnel to carry out the tests. There are more than 70 coronavirus drug and vaccine trials now registered with the Food and Drug Administration. Many, but not all, are taking place in the U.S. Although the number of new coronavirus infections nationwide is still climbing, the frenetic pace at which trials are launching 鈥 and the number that are potentially redundant or don鈥檛 involve enough patients to reach accurate conclusions 鈥 could prevent some of these studies from producing useful results. (Brennan, 4/30)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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