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Asp2151 Japan update help?

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Whyyyyy

I read the article and it stated that it has been approved for singles and HSV...in different doses. How reliable is the source of the article though is the question?

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StayingPositive17

Time to do some investigation

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useless

Can't someone email them or something?  I think there is a Japanese member on the forum.

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Whyyyyy
17 minutes ago, useless said:

Can't someone email them or something?  I think there is a Japanese member on the forum.

Yes, I tagged him... @House of Herpesians

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Roberto Z

Does anyone knows what the clinical results were with respect to viral shedding? And fda progress... even the phase 3 trials were registered in clinicalgov website.

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medicalanonymo

Guys

 

  Tranalation of the full article in English from Google Translate - figure it out ..

The Ministry of Health, Labor and Welfare Ministry 's Second Drug Deliberation Drug Sub - committee deliberated and approved the approval of 5 new drugs such as JAK inhibitor Ortiento tablet for rheumatoid arthritis filed for application by Eli Lilly Japan on May 30.

[Items to be deliberated and its contents] (In parentheses, general name and application company name)
▽ Amenalife tablet 200 mg (Amenameville, Maruho): A new active ingredient-containing medicine that makes "shingles" effective / effective. Re-examination period 8 years.


It inhibits the activity of the helicase / primase complex on DNA replication of herpesvirus, and shows antiviral effect. 400 mg once a day was administered once a day after meals. There are acyclovir, valacyclovir and famciclovir as classified drugs. There is no approval example abroad.
 
▽ Somatulin subcutaneous injection 120 mg (Lanreotide acetate, Teijin Pharma): New indication / new dose medicine to add "pancreatic · gastrointestinal neuroendocrine tumor" to indication / effect. Re-examination period 4 years.

It has an effect of suppressing the secretion of growth hormone, and it is expected to suppress tumor growth and improve symptoms. 120 mg subcutaneously in the deep portion every 4 weeks. One of treatment options for pancreatic and gastrointestinal neuroendocrine tumors. Overseas, the indications to be added this time have been approved in 46 countries and regions including Europe and the United States (as of February 2017).
 
▽ Istdax 10 mg for intravenous infusion (Romidepsin, Celgene): A new active ingredient-containing medicine that treats "recurrent or refractory peripheral T cell lymphoma" as an indication and effect. Medicines for rare diseases. Re-examination period 10 years.

Histone deacetylase (HDAC) inhibitor. Inhibition of the activity of HDAC induces cell cycle arrest and cancer death of the cancer and is supposed to suppress tumor growth. HDAC inhibitors have already been approved for products from other companies, but drugs with indications for peripheral T cell lymphoma are the first time. Overseas, it has been approved in 5 countries including the United States (as of March 2017).
 
▽ Ormiento tablets 2 mg, same 4 mg (Bali Sitinib, Japan Eli Lilly): "New active ingredient-containing medicine that treats rheumatoid arthritis insufficiently effective in existing treatments (including the prevention of structural damage of joints)" as an indication and effect. Re-examination period 8 years.

Selective JAK1 and JAK2 inhibitors. It has been suggested that JAK-dependent cytokines are related to the pathogenesis of many inflammatory and autoimmune diseases, and it is thought that JAK-dependent cytokines exert their effects by the action of JAK inhibition. 4 mg once daily. Depending on the condition of the patient it can be reduced to 2 mg. As a JAK inhibitor to be used for rheumatoid arthritis, there is Pfizer 's Zerjant tablet (tofacinib citrate).
 
In overseas, in February 2017 in Europe, 4 mg once a day has been approved as basic usage and dose. In the United States, it was filed in January 2016, and from the FDA in April 2017, it can not approve with the contents of the application as it is, additional clinical data is required to determine the optimal dose. In addition, additional data is required for further study of safety concerns of each treatment group. On the other hand, Eli Lilly said it did not agree with the FDA's view, and the FDA will discuss the timing of future reapplication. An official of the Ministry of Health, Labor and Welfare explained that it was judged that it would be safe to approve as a result of examination including concerns such as usage and dosage.

Laria subcutaneous injection 60 mg syringe (Denosumab (Genetical recombination), Daiichi Sankyo): "Inhibition of the progression of bone erosion associated with rheumatoid arthritis" New indication / new dose medicine with efficacy / effect. Re-examination period 4 years.

It is used by additionally administering it to a patient who has advanced bone erosion even after treatment with disease modifying antirheumatic drugs (DMARDs). It is used by subcutaneously administering 60 mg of this agent subcutaneously once every 6 months, but can be administered subcutaneously once every 3 months if bone destruction is observed once every 6 months.

Human monoclonal antibody targeting RANKL. Inhibiting the binding of RANKL and RANK inhibits bone resorption by osteoclasts and inhibits the progression of joint destruction. Overseas, Phase 2 trials were conducted for rheumatoid arthritis by rice Amgen, but no further development has been done.

【Items to be Reported and Its Content】 (In parentheses, general name and application company name)
The items to be reported are those whose approval was approved at PMDA's appraisal stage and it was judged that deliberation at the subcommittee was not necessary.

Actemra subcutaneous injection 162 mg syringe, same 162 mg autoinjector (tocilizumab (genetical recombination), Chugai Pharmaceutical): "Improve rheumatoid arthritis (including prevention of structural damage of joints)" New dose medicine.

Currently it is used at 2-week interval administration, but if the effect is insufficient this time, the administration interval should be shortened up to 1 week. In Europe and the US, administration at 1 week intervals is permitted.

Stiberga Tablet 40 mg (Legolafenib Hydrate, Bayer Pharmaceutical): A new efficacy pharmaceutical that adds the efficacy and effect of "unresectable hepatocellular carcinoma exacerbated after cancer chemotherapy". Priority review item. The reexamination period is the remainder (March 24, Heisei 33).

Dosage regimen is the same as 'adaptive healing unresectable progression · recurrent colon · rectal cancer' with adaptation. Overseas, the indication for hepatocellular carcinoma has been approved in the United States in April 2005, under examination in Europe (filed in November 2004)

 

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medicalanonymo

The first point is Amenoleaf and it says re-examination is 8 years. and no approval example. But definitely it is first under the heading "5 drugs approved by Health Ministry" .. so I am guessing it's _________. Let's hope for the best -

Amenalife tablet 200 mg (Amenameville, Maruho): A new active ingredient-containing medicine that makes "shingles" effective / effective. Re-examination period 8 years.


It inhibits the activity of the helicase / primase complex on DNA replication of herpesvirus, and shows antiviral effect. 400 mg once a day was administered once a day after meals. There are acyclovir, valacyclovir and famciclovir as classified drugs. There is no approval example abroad.

 

 

Edited by medicalanonymo

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medicalanonymo

I think it's for both Shingles and HSV based on prior discussion on this thread. Let's hope the best.

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medicalanonymo

Why is there only one Japanese person on this forum, aren't only one a virgin?

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StayingPositive17

Guess everyone will be flying to Japan instead of Russia

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Roberto Z

Do we know how it compares to valtrex or how it diminishes viral shedding?

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StayingPositive17

Just got approve today. Might be a few weeks before we know anything 

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Whyyyyy

What does "re-examination period: 8 years mean?"

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Whyyyyy

They'll see how it does and re examine in 8 years? It'll reach the market in 8 years? So confused...

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medicalanonymo

I checked if it was examination or re-examination.

It's defintely  "re-examination" = 再審査  , period = 期間  , 8 years = 8年 . while "Examination" = 検査

In the article they have used  再審査 (re_examination). So it seems like maybe it's not approved and they need to re-examine for another 8 year period.

Maybe that's why our Japanese person is not replying anymore.

Let's hope for the best.

 

Edited by medicalanonymo

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Whyyyyy
12 minutes ago, medicalanonymo said:

I checked if it was examination or re-examination.

It's defintely  "re-examination" = 再審査  , period = 期間  , 8 years = 8年 . while "Examination" = 検査

In the article they have used  再審査 (re_examination). So it seems like maybe it's not approved and they need to re-examine for another 8 year period.

Maybe that's why our Japanese person is not replying anymore.

Let's hope for the best.

 

Hopefully not more bad news :(

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dont quit!17

Please read the thread. All your questions have already been answered. 

With that being said. This is a good day and the best news I've heard since I've been infected (4-5yearz ago). @House of Herpesians, are there any further details that Google translate botched up in? 

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srinivas

For most of drugs it is mentioned as "re-examination " it mean these drugs has to re check for mention  period. I don't understand "No approval example abroad". It mean that this drug is not approved in other countries and approved in Japan??. Any ideas..  Let's hope for the best.... 

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House of Herpesians

Hi, ALL (^^)/

As some of you noted here, Amenolief is formally approved at the meeting of the Ministry!! This is a really great news for us!! (^^)/

However, looking at the list of new drugs approved at the meeting, Amenamevir was approved as the next candidate with new function effective for 'simple shingling', not for 'genital herpes'. The details of the meeting will be uploaded later in a few weeks. Please give me more time until I check the document...

As for the meaning of 再審査, it doesn't mean that the drug candidate should be re-examined again; it means in this context that the drug's efficacy and safety shall be re-examined in eight years after its formal approval. So Don't Worry!!

 

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House of Herpesians
2 hours ago, medicalanonymo said:

The first point is Amenoleaf and it says re-examination is 8 years. and no approval example. But definitely it is first under the heading "5 drugs approved by Health Ministry" .. so I am guessing it's _________. Let's hope for the best -

Amenalife tablet 200 mg (Amenameville, Maruho): A new active ingredient-containing medicine that makes "shingles" effective / effective. Re-examination period 8 years.


It inhibits the activity of the helicase / primase complex on DNA replication of herpesvirus, and shows antiviral effect. 400 mg once a day was administered once a day after meals. There are acyclovir, valacyclovir and famciclovir as classified drugs. There is no approval example abroad.

 

 

Please check my previous post concerning 'Re-examination'.

About 'There is no approval example abroad' I also checked its original text in Japanese. It should be 'Similar drugs have not yet been approved in other countries'.

If you have any further questions, let me know (^^)/

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medicalanonymo

In an earlier post on this thread there was a confimration from Maruho website on their development timelines -

Quote

See company's pipelines HSV phase 3 as of September 2016

https://www.maruho.co.jp/sp/english/aboutmaruho/activities/randd/pipeline.html

 

For Herpes Zoster (Shingles) it was:

Quote

M5220 - Herpes Zoster   - Oral - JP - PhaseIII (Apr 2016 filed - as of Sept 2016)

And for HSV it was:

Quote

M251OB - Herpes Simplex - Oral - JP - PhaseIII (as of Sept 2016)

 

So is  Amenolief the same as M251OB (for Herpes Simplex)? Or is it M5220 (for Herpes Zoster) ?

-------------------------------------------------------------

 

Also gathering all old information here that helps to connect the dots -

Quote


 -> The end dates on the clinical trials show the Phase 3 trial should have ended mid this year. However, I can't see ASP2151 mentioned in Astellas's website under Pipleine Drugs. The latest news I found is below. http://adisinsight.springer.com/drugs/800025919

->  ASP2151 is known as M5220 in their portfolio. https://www.maruho.co.jp/english/contact/index.php?action_English_Contact_Lb=true

 -> I found another link. The original link contains weird technical terms, so following link will be better to read. All information is written in Japanese. If you are not so good at the language, please ask somebody who can understand Japanese to help you read the page: https://www.mixonline.jp/Article/tabid/55/artid/57514/Default.aspx ( If the proposal is approved at the meeting, the ministry will quickly allow the company (Astellas) to start the production and sales of the drug.)

 

Edited by medicalanonymo

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dont quit!17
5 minutes ago, House of Herpesians said:

Hi, ALL (^^)/

As some of you noted here, Amenolief is formally approved at the meeting of the Ministry!! This is a really great news for us!! (^^)/

However, looking at the list of new drugs approved at the meeting, Amenamevir was approved as the next candidate with new function effective for 'simple shingling', not for 'genital herpes'. The details of the meeting will be uploaded later in a few weeks. Please give me more time until I check the document...

As for the meaning of 再審査, it doesn't mean that the drug candidate should be re-examined again; it means in this context that the drug's efficacy and safety shall be re-examined in eight years after its formal approval. So Don't Worry!!

 

Thank you for rapid response. I think it is good news especially for you, being that you live in Japan. Many questions to be asked. I wonder how long it will take for you to be able to get? Would you be able to get off label? You know like getting it prescribed by your MD even though it is approved for shingles.  

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thehopeisnear

So I'm a little confused - Amenalief was approved or amenavir was approved ?  

Maruho's lists the drugs as two different medications.  

Is there news coverage on this ?

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Whyyyyy

Great that it was approved! Now the hurdle of seeing if it'll be prescribed for HSV and getting it if you don't live in Japan. 

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