Avigan Antiviral

U.S. Invests $3 Billion to Accelerate Antiviral Medicines

Don Hackett — Thu, 17 Jun 2021 21:36:52 +0000

Reviewer:

The U.S. government announced it is investing more than $3 billion to accelerate the discovery, development, and manufacturing of antiviral medicines as part of the whole-of-government strategy to develop the next generation of COVID-19 treatments.

Through collaboration within the U.S. Department of Health and Human Services (HHS), including the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases, and the Biomedical Advanced Research and Development Authority, this plan called the Antiviral Program for Pandemics will respond to the urgent need for antivirals to treat COVID-19 by spurring the availability of medicines to prevent serious illness and save lives, stated an NIH press statement issued on June 17, 2021.

The Antiviral Program for Pandemics plan also will build sustainable platforms for the discovery and development of antivirals for other viruses with pandemic potential, helping better prepare the nation to face future viral threats.

Even as hundreds of millions of Americans get vaccinated against COVID-19 and cases, hospitalizations, and death rates fall, the U.S. Administration remains committed to identifying effective treatment options that can prevent people diagnosed with COVID-19 from progressing to severe illness and death.

Highly effective oral antiviral medicines that can be taken at home early in the course of infection, similar to antiviral treatment for influenza, would save lives both here and abroad and prevent overwhelming surges in hospitalizations.

This plan will support research to identify and accelerate the availability of breakthrough treatment options to ensure the public has access to viable medicines.

This plan accelerates and expands the Administration’s ongoing efforts to support clinical trials to test prioritized drug candidates for COVID-19 and support the advanced development of promising therapies. Working through an unprecedented public-private partnership called ACTIV (Accelerating COVID-19 Therapeutics and Vaccines), 19 therapeutic agents have been prioritized for testing in rigorous clinical trials for outpatients and inpatients with COVID-19.

“The remarkable and rapid development of vaccines and testing technology has shown how agile scientific discovery can be when we combine the resources of public agencies, private entities, and our nation’s most brilliant and creative minds,” commented Dr. Francis S. Collins, NIH Director.

“We will leverage these same strengths as we construct a platform for the discovery and development of effective antivirals that will help us defeat COVID-19 and better prepare us for potential future viral pathogens.”

As part of the plan announced today, the NIH will evaluate, prioritize and advance antiviral candidates to Phase 2 clinical trials, using current and expanded contract resources and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early-stage development with sponsors and guide candidates along development paths.

The new plan provides more than $300 million for research and lab support, nearly $1 billion for preclinical and clinical evaluation, and almost $700 million for development and manufacturing.

Additionally, the plan allocates up to $1.2 billion to support creating collaborative drug discovery groups called Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern that will harness the creativity of the biomedical research community and drive innovative antiviral drug discovery and development.

These centers will create platforms that will initially target coronaviruses and then could be expanded to other viruses with pandemic potential, helping to prepare the nation for future viral threats.

The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency, making important discoveries that improve health and save lives. The NIH traces its roots to 1887, when a one-room laboratory was created within the Marine Hospital Service, the predecessor agency to the U.S. Public Health Service.

PrecisionVacciations publishes research-based news.

Sub Title:

Antiviral Program for Pandemics will respond to the urgent need for antivirals to treat COVID-19

References:

Biden Administration to Invest $3 Billion from American Rescue Plan as Part of COVID-19 Antiviral Development Strategy

Antiviral Program for Pandemics

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Friday, June 18, 2021 - 05:15

Coronavirus Medicine Gains Worldwide Partners

Don Hackett — Thu, 02 Jul 2020 16:46:26 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Tokyo Japan-based Fujifilm Corporation announced a partnership concerning the global development, manufacture, and sales of its influenza medication, Avigan® Tablets (favipiravir),

Fujifilm stated on June 1, 2020, it will exclusively partner with India's Dr. Reddy’s Laboratories Ltd., and Dubai-based Global Response Aid for the worldwide distribution of Avigan excluding Japan, China, and Russia.

Because it has a mechanism of action that selectively inhibits viral RNA polymerase, thereby preventing viral proliferation, Avigan may have an antiviral effect on the novel SARS-CoV-2 coronavirus, as it is classified into the same type of RNA virus as influenza viruses, commented this press statement.

Avigan is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses.

The Fujifilm Group is currently conducting a clinical study on Avigan targeting COVID-19 patients in Japan and the USA and is working to increase the drug’s production by partnering with domestic and overseas companies.

Based on the Agreement, Fujifilm Toyama Chemical will provide Dr. Reddy’s and GRA an array of data on Avigan’s preclinical and clinical studies that Fujifilm has accumulated thus far.

Dr. Reddy’s and GRA, for their part, will make use of this data to swiftly implement clinical studies, targeting COVID-19 patients in India, the Middle East, and other regions where infections have been spreading.

In addition, Fujifilm Toyama Chemical will grant Dr. Reddy’s right to use Avigan’s patents of formulation and manufacturing methods.

Dr. Reddy’s will herewith establish a setup for manufacturing drugs of the same quality as Avigan, and utilize GRA’s global sales network to supply the manufactured drugs swiftly and in a stable manner.

Dr. Reddy’s is a global pharmaceutical company that develops, manufactures, and sells generic drugs. It has been expanding business not only in India but also in Europe, the US and several other markets across the world and is accelerating its global business development.

GRA, a company based in Dubai, offers medical supplies, drugs, and medical services worldwide in cooperation with drug and medical device manufacturers.

Previously, on February 17, 2020, China’s National Center for Biotechnology Department, said that in human trials conducted in Shenzhen, Guangdong province, Avigan showed promising results against the novel coronavirus and mild adverse reactions in patients.

In India, Glenmark Pharmaceuticals Ltd received regulatory approval for favipiravir, the generic form of Avigan, as a treatment for mild-to-moderate virus infections in June.

And in Russia, the Ministry of Health issued a temporary registration certificate for Avifavir (Avigan) on June 1, 2020.

In early June, the first batches of Avifavir will be sent to Russia's Federal Service for Surveillance in Healthcare (Roszdravnadzor) for approval for use.

The drug is undergoing clinical trials in Moscow, Saint-Petersburg, Tver, Nizhny Novgorod, Smolensk, Ryazan, Kazan, Ufa, and in the Republic of Dagestan.

The efficacy of the drug was reported above 80 percent, a criterion for a drug with high antiviral activity.

Precision Vaccinations publishes coronavirus therapeutic development news.

Sub Title:

Avigan (favipiravir) partners include Dr. Reddys and Global Response Aid

References:

Fujifilm partners with Dr. Reddy’s and Global Response Aid for deployment of a COVID-19 treatment drug outside of Japan

Russia Approves Avifavir For COVID-19 Treatment

Avigan Antiviral Medication

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