Indonesia OKs Avigan® (Favipiravir) for COVID-19 TreatmentDT News
DUBAI – September 10, 2020 – Global Response Aid (GRA) and Dr. Reddy’s Laboratories will begin selling the anti-viral drug Avigan® in Indonesia following a recent decision by the country’s National Agency of Drug and Food Control (NA-DFC) to approve the drug’s active ingredient, Favipiravir, for treatment of patients infected with COVID-19.
The approval by Indonesia’s national medicines regulator follows a similar decision in August by the medicines regulatory body of India, the Central Drugs Standard Control Organization (CDSCO), which approved Avigan® as a treatment for patients infected with Coronavirus.
Avigan® was developed as an influenza anti-viral by FujiFilm, which has licensed GRA and Dr. Reddy’s to manufacture, distribute and commercialize the drug globally. Clinical trials of the drug have been conducted and are underway in the United States, Japan, China, the Middle East and other countries, where it is being used to reduce fevers and shorten recovery time in patients who receive Avigan® in the early stages of infection with COVID-19.
Throughout the pandemic, the governments of Indonesia and Japan have been collaborating on the search for effective treatments and other challenges. In May, the Japanese government delivered more than 12,000 Avigan® tablets to Indonesia for use in fighting COVID-19.
With the drug now approved for use, GRA and Dr. Reddy’s will distribute Avigan® in Indonesia through private healthcare providers opting for a premium quality drug.
“Generic versions of Favipiravir are or will be available in Indonesia, India and other markets as it gets addditional regulatory approval and becomes accepted as a safe, effective treatment for COVID patients,” said Eric ten Kate, Head of Life Science at GRA. “GRA’s focus is getting branded Avigan®, the premium version of the drug, to providers and patients who want the original formulation, which has a higher potency, fewer impurities and five times the shelf life. Our goal is to provide the safest, most effective version of Favipiravir available anywhere.”
Mitch Wilson, CEO of GRA, said: “Approval by Indonesia means that Avigan®/Favipiravir is now being used to treat patients in the three most populous Asian countries – China, India and Indonesia. We expect further approvals in the near future and will be announcing multiple manufacturing locations globally to meet the growing demand.”
“The diligent and efficient work GRA and Dr. Reddy’s are conducting is the reason we chose them as our partners,” said Junji Okada, President, FUJIFILM Toyama Co., Ltd.
Avigan® was approved for manufacture and sale in Japan in 2014 as an influenza anti-viral drug. It has generally been used only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza anti-viral drugs are either not effective or insufficiently effective.
Working with government agencies, non-governmental organizations and local regulatory authorities, GRA is providing Avigan® to qualified patients with COVID-19 on a compassionate-use basis for emergency treatment outside of ongoing clinical studies.