- Generic drugmakers Teva and Mylan will ramp up production of a decades-old malaria pill that's drawn substantial attention in efforts to repurpose existing drugs as treatments for the new coronavirus.
- Teva said it would donate 6 million tablets of one version of the drug, called chloroquine, to hospitals by the end of the month, while Mylan disclosed plans to restart manufacturing at its sprawling drug plant in West Virginia. On Friday, meanwhile, Swiss pharma Novartis said it would donate up to 130 million doses if it's cleared for use by regulators.
- Chloroquine is not approved to treat COVID-19, the illness caused by the new coronavirus. But small studies conducted in China and in France suggest it could be beneficial in clearing the virus — potential that President Donald Trump seized on at a Thursday press conference in which he incorrectly implied it had already been approved.
But the drug and its various forms are well-known to physicians, having been used since the 1950s for malaria and, later, arthritis and lupus. And, as a generic pill, it could be manufactured at the scale necessary to combat a global pandemic should its benefit be proven.
Teva's and Mylan's announcements Thursday, and Novartis' Friday, are therefore important, particularly as one of the chloroquine formulations is currently in short supply, according to the American Society of Health-System Pharmacists.
The planned donation from Novartis should help, as will Teva's and a similar move by Bayer to donate 3 million tablets of its chloroquine phosphate formulation. Teva and Novartis also said they will assess expanding production.
Mylan could play a large role, indicating it expects to start supplying product by mid-April and potentially ramp up manufacturing to provide enough drug for 1.5 million patients. Other companies, including Zydus Pharmaceuticals, Prasco Labs and Sun Pharmaceuticals, also make forms of chloroquine.
Larger studies to prove how beneficial chloroquine actually is are now getting underway.
In the Thursday press conference, Food and Drug Administration Commissioner Stephen Hahn said Trump instructed the agency to take a closer look at expanding access to coronavirus-infected patients.
"We want to do that in the setting of a clinical trial — a large, pragmatic clinical trial — to actually gather that information and answer the question that needs to be answered," Hahn said.
Chloroquine will also be studied in an "umbrella" trial organized by the World Health Organization, which will also study an experimental antiviral called remdesivir and developed by Gilead.
That chloroquine is being considered so seriously as a potential treatment reflects the urgency with which governments and researchers are moving. Results from the French study looked encouraging, but the trial was very small and its design means clear conclusions are difficult to draw.
While a number of drugmakers, including Johnson & Johnson, Sanofi and Moderna, are developing vaccines, experts expect the earliest one would be available is 12 to 18 months from now. The first human study in the U.S., testing Moderna's messenger RNA vaccine, began this week.
Existing drugs could be a stopgap option but, as one of the first studies to read out results showed this week, won't always prove to be effective.
Apart from chloroquine, Gilead's remdesivir appears the clearest near-term hope. Five studies of the drug are ongoing and could deliver data as soon as April. But unlike chloroquine, which is given orally, remdesivir is infused over multiple days, potentially limiting its use to severe patients.
More than 10,000 Americans are confirmed to have been infected through March 19, with 150 deaths reported. Concerns have grown that hospitals in hard-hit areas like New York, California and Washington could quickly become overwhelmed with cases.