Ampligen now commercially available in Argentina for severe ME/CFS

[bobby]

http://www.globenewswire.com/news-release/2016/08/23/866212/0/en/Hemispherx-Biopharma-Announces-Major-Breakthrough-Approval-for-Commercial-Sale-of-Rintatolimod-U-S-Tradename-Ampligen-to-Treat-Severe-Cases-of-Myalgic-Encephalomyelitis-Chronic-Fat.html
Hemispherx Biopharma Announces Major Breakthrough: Approval for Commercial Sale of Rintatolimod (U.S. Tradename: Ampligen®) to Treat Severe Cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the Argentine Republic

First Product Approved for ME/CFS Indication Anywhere in the World
Breakthrough Approval Provides Clear Path for Growth in Latin America and the European Union​

 

[Cort]

A

http://www.globenewswire.com/news-release/2016/08/23/866212/0/en/Hemispherx-Biopharma-Announces-Major-Breakthrough-Approval-for-Commercial-Sale-of-Rintatolimod-U-S-Tradename-Ampligen-to-Treat-Severe-Cases-of-Myalgic-Encephalomyelitis-Chronic-Fat.html
Hemispherx Biopharma Announces Major Breakthrough: Approval for Commercial Sale of Rintatolimod (U.S. Tradename: Ampligen®) to Treat Severe Cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the Argentine Republic

Good start!

I just posted Anita's fantastic recovery story in the recovery stories section - http://www.healthrising.org/forums/recovery-stories/ampligen-does-the-trick-for-anita.380/ - She went from horribly ill - at one point she even lost her sight - to bouncing around town with Ampligen. She lives near Incline Village so I usually see her when I go up there. She's a bundle of energy now - she was a great responder.

Check out her post - What Ampligen means to me - http://www.healthrising.org/testimonials-2/anita-patton-what-ampligen-means-to-me/

It could bring some much needed money to Hemispherx

The approval was based on submission of two pivotal studies, AMP-502 and AMP-516. Safety data also included additional CFS and non-CFS studies for a total of over 800 subjects including over 100 subjects with severe CFS who received Ampligen® for one year or longer. Several post-approval activities are required to be completed before product launch, including manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina.

Approval for commercial sale in Argentina provides a platform for potential commercial sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of licensed drugs. Hemispherx and GP Pharm are now working to expand the approval of rintatolimod to additional countries with a focus on Latin America. In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, adds further validation for the product as the Early Access Program (EAP) is launched in Europe.

• Check out Health Rising's Ampligen Chronic Fatigue Syndrome Resource Center here.

 

[bobby]

important side note from Mary Dimmock on FB

Approval is for the severe form of ME/CFS. This does not automatically translate to approval in the United States or to other countries and they still need to work through "reimbursement evaluation" with Argentina."

 

[Cort]

Granted that it doesn't apply to the U.S.. I think the important thing, here, is that another country has agreed that the evidence warrants approval for the drug. Even if Hemispherx stumbles on the reimbursement evaluation - and hopefully it won't - the fact is that the drug was approved for ME/CFS. Hemispherx states Argentina has a rigorous drug approval process. It would be good to find out more about that.

important side note from Mary Dimmock on FB

 

[bobby]

Granted that it doesn't apply to the U.S.. I think the important thing, here, is that another country has agreed that the evidence warrants approval for the drug.

I agree! it is a very important step forward. it makes a very good case for other countries trying to get ampligen available.