Japanese drug making waves treating coronavirus. Will it come to U.S.?

[Boats]

Japanese drug making waves treating coronavirus. Will it come to U.S.?
By: Emily Bamforth - Cleveland News - 03-19-20
Re: https://www.cleveland.com/news/2020/...ome-to-us.html

Photo link: https://www.cleveland.com/resizer/9I...CCSLPGPLVU.jpg
A laboratory technician prepares COVID-19 patient samples for semi-automatic testing at Northwell Health Labs, Wednesday, March 11, 2020, in Lake Success, N.Y. The U.S. Food and Drug Administration has approved faster testing protocols as the viral outbreak continues to spread worldwide. For most people, the new coronavirus causes only mild or moderate symptoms. For some it can cause more severe illness. (AP Photo/John Minchillo)AP

CLEVELAND, Ohio -- A new Japanese drug is making headlines around the world for its effectiveness in treating coronavirus symptoms in clinical trials, but whether it would make its way to the U.S. is complicated.

The drug is called Avigan or favipiravir, and it is normally used in Japan to treat new strains of influenza. Zhang Xinmin, an official at China’s science and technology ministry told The Guardian that health outcomes improved for patients taking the drug in clinical trials involving 340 coronavirus patients in China.

The drug is not as effective after the virus has already multiplied in more severe cases, according to early results described by a Japanese health official to newspaper Manichi Shimbun. Testing on patients with mild to medium symptoms began this month. Japan has a stockpile of about 2 million Avigan pills.

Another Japanese drug, remdesivir, has already been used to treat American patients aboard the Diamond Princess cruise ship, reports the Wall Street Journal.

Whether drugs could potentially be used to treat coronavirus symptoms in the United States depends on whether the FDA approves use and import of the drugs, and whether manufacturers in Japan approve enough for export, said Mahesh Srinivasan, director for the Institute for Global Business at the University of Akron.

The FDA did not return a phone call for comment on whether they would fast-track approval or do inspection overseas for any coronavirus therapies in foreign countries.

Government approval
Favipiravir is not currently approved for coronavirus treatment in Japan, and when it would gain approval would depend on clinical research results.

As of Wednesday, favipiravir is not approved by the FDA. Remdesivir is approved, but only for ebola treatment.

Srinivasan said the agency would balance the need for the drug with the public’s safety.

“If they see promise and there’s a lot of people in the clinical field who will tell them (if) it’s promising or not, they may try to speed it up. It’s amazing. I mean, we’ve seen things which take months -- they are doing it in days. So there’s a will, they will do it.”

Companies are working on rapidly developing vaccines and anti-viral treatments in the United States. The first patient was injected with a potential coronavirus vaccine in Seattle this week.

For foreign companies, the FDA needs to do inspections to make sure facilities are meeting the U.S. standards.

On Tuesday, the FDA announced it would postpone foreign inspections in April not deemed “mission-critical,” though potential therapies for coronavirus were not specifically mentioned.

The FDA has options for loosening restrictions on foreign imports, though this seems to be more in the case of individual prescriptions and not bulk distribution. There are expedited processes for drugs that fill a need, but it’s unclear whether they would apply here.

Importing the drug
When a therapy for coronavirus is developed and approved, it would be in a huge demand around the world.

“What most countries -- I think -- are doing or are going to start to do is treat(ing) many of these drugs and not only drugs, right, anything like medical equipment, like masks, respirators, everyday things like that, as things of national interest,” Srinivasan said.

“When they do that, that helps them put in export curbs."

India already applied restrictions on certain drugs and drug ingredients to ensure there would be enough for Indian citizens after shortages from Chinese imports.

The Guardian reports that in 2016, the Japanese government supplied favipiravir as an emergency aid to counter the Ebola virus outbreak in Guinea.

But scientists in the United States are also working on treatments for coronavirus. A team of hundreds of scientists has identified 50 drugs that may be effective treatments for people infected with the coronavirus, the New York Times reported on Tuesday.

Note: Many of those drugs are pivoting from existing therapies as well.

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Personal note: It seems we may be getting pretty close to getting it contained and a treatment to put this virus to rest? Let's hope so.

Boats