India Approves Avigan (Favipiravir) for COVID-19 Treatment
Global Response Aid and Dr. Reddy’s Laboratories will begin selling the anti-viral drug Avigan® in India following a recent decision by government health authorities to approve the drug’s active ingredient, Favipiravir, for treatment of patients infected with COVID-19. This important ruling is the result of proven efficacy from the widespread use of the drug.
Avigan® was developed as an influenza anti-viral by FujiFilm, which has licensed GRA and Dr. Reddy’s to manufacture, distribute and sell 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.
In India, GRA and Dr. Reddy’s will look to distribute Avigan® through private healthcare providers opting for a premium quality drug. The initial supply will contain the original Avigan®, made in Japan.
“Generic versions of Favipiravir are available on the market in India,” said Eric ten Kate, Head of Life Science, GRA. “Our focus is getting branded Avigan®, the premium version of the drug, to providers and patients who prefer 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: “This is an important milestone in the regulatory approval process for Avigan. We are expecting 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.
In July, the Central Drugs Standard Control Organisation of India’s Directorate General of Health Services approved Favipiravir for distribution, sale and use in treatment of COVID-19 patients.
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.
