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Japanese drugmaker Shionogi to seek approval for oral COVID drug

22 Comments

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Whatever happened to AVIGAN? Remember the govt and media were touting that for the longest time as the miracle drug?

then nothing, a complete bust. Hope this just isn’t AVIGAN 2.

11 ( +12 / -1 )

Where can people apply for the trial ??

9 ( +10 / -1 )

@stickman1760

Avigan was pushed by Abe and derided by pretty much everybody else.

https://www.nytimes.com/2020/05/05/business/japan-avigan-coronavirus.html

But again Fuji Film seemed to have been one of Abe's bosom friend's companies.

https://toyokeizai.net/articles/-/349269?page=3

The company plans to apply for fast-track approval by the health ministry, which does not require it to complete clinical trials before putting the drug on the market, provided it conducts necessary study afterward.

No clinical trials this time?

How bizarre. On the other hand, foreign remedies needed cosmetic clinical trials in Japan, trials which most said didn't bring anything to the topic except wasting time we didn't have...

10 ( +12 / -2 )

What’s the plan, JAPAN ??

3 ( +4 / -1 )

In case you were wondering the name is S-217622 and is a protease inhibitor.

6 ( +6 / -0 )

@blue

No clinical trials this time?

Not exactly. It just means the drug would get fast track release before the trials are completed. The article mentions they have been doing clinical trials since July. Once sufficient efficacy and safety data exists from those trials the drug would be granted fast-track approval. Presumably the studies would still be completed and they will seek full approval later. Also they will need to undertake surveillance to monitor for adverse effects.

7 ( +7 / -0 )

@Fuzzy

Thanks, appreciated. This clarifies things.

Going back to the article, and looking at the J-government's attempt to push Avigan, I remain nervous about a new local drug though. I would definitely appreciate the independent feedback of a foreign authority on the efficiency, side-effects, etc.

0 ( +1 / -1 )

Whatever happened to AVIGAN? Remember the govt and media were touting that for the longest time as the miracle drug?

Ministry of health has tested Avigan for many months, but it turned out to be not effective for Covid19 for Japanese. Avigan is an influenza medicine in the first place.

4 ( +4 / -0 )

However when you are infected with covid19, if you ask Avigan to doctor, if you really want it, you can have it on your responsibility.

0 ( +0 / -0 )

Would you really trust a drug that will be approved based on political connections rather than any conclusive evidence?

6 ( +6 / -0 )

Earlier in the day, was willing to “give it a go” but, …

0 ( +0 / -0 )

… if that’s a potential ‘side effect’, … perhaps it’s not for people?

*- @Kentarogaijin 5pm**: “Go Shionogi, Go Japan !!.. Let the haters bark ”*

Probably best to leave the endorsements to experts and professionals?

3 ( +3 / -0 )

An oral covid drug is probably nothing more than cold medicine with enhanced fever reducing and cough suppressing elements.

-4 ( +1 / -5 )

This could be a real game changer, especially if it can be shipped, stored, and dispensed in Third World countries.

4 ( +4 / -0 )

I believe Fuji Film allowed the rights to Avigan and to sales worldwide to be sold to China.

0 ( +0 / -0 )

BlackFlagCitizen, there is another Oral covid19 vaccine now going into Phase III Trials. Google Vaxart.

0 ( +0 / -0 )

Applied at a very early stage, maybe some helpful. But considering an about 1200-fold virus load with delta compared to former variants, it’s also probably not the one and only final solution.

-1 ( +0 / -1 )

I hope the authorities in Japan take their time to ensure the drug is safe for non-Japanese.

2 ( +2 / -0 )

There already is an oral drug to cure Covid and it is called Ivermectin which is an anti-parasitic drug which has been used safely for more than 30 years. Asked our doctor about getting some but he said he can't give it. Available over the counter in Mexico and available from a Doctor's organization in the USA.

The shame of it all it was discovered by a Japanese scientist from which he received a Nobel prize and yet there is a refusal to make it readily available in Japan and some other countries. Many testimonies to it's life saving effects can be found online and in Youtube video comments providing that the videos have not been removed.

-1 ( +0 / -1 )

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