Global Response Aid (GRA) and Dr Reddy’s Laboratories will make Avigan® available in Malaysia following a recent decision by the Malaysian Ministry of Health’s Drug Control Authority to approve the anti-viral drug for the treatment of patients infected with COVID-19.
The Malaysian Drug Control Authority’s approval of Avigan® is recognition of the urgent need to provide safe and effective treatment solutions to patients diagnosed with Coronavirus. It follows recent decisions by regulatory bodies in Indonesia and India to approve Avigan® for treatment of COVID-19 patients.
FujiFilm Toyama Chemical developed Avigan® as an influenza anti-viral. In June, FujiFilm signed an agreement with GRA and Dr Reddy’s for the exclusive global production, distribution and commercialization of the drug. The joint venture has participated in an array of clinical trials of Avigan®, including large studies in the Middle East and five Phase 2 and Phase 3 studies in the United States, Japan, China and the UAE. The drug has shown positive results, reducing fevers and shortening recovery time in patients in the early stages of COVID-19 infection.
Originally developed for influenza, Avigan® or its generic has been used to treat up to 400,000 patients. Avigan® is available in tablet and IV form. It is stable and easy to transport without the need for refrigeration and has a shelf life of ten years.
Mitch Wilson, CEO of GRA, said: “Avigan is increasingly being adopted as a first-line defence because it can reduce the likelihood that patients in high-risk categories will ultimately require hospitalization. Approval by Malaysia expands availability and means that Avigan® is now available to treat more than 3 billion people in China, Indonesia, India and Malaysia. It has become a vital tool in global and national efforts to stave off a potentially disastrous next wave of COVID-19. We expect further approvals in other countries shortly and will be announcing multiple manufacturing locations to meet the growing global demand.”
Wilson said GRA “is grateful to the Malaysian Ministry of Health’s Drug Control Authority for their leadership and collaboration, as we work together to respond to this public health emergency. We are prepared to supply Avigan® as directed by government health authorities.”
Junji Okada, President of FujiFilm Toyama, said: “As our joint venture partners GRA and Dr Reddy’s continue to advance their critical regulatory milestones to make Avigan® available globally, the ever-growing need for effective treatment is becoming more crucial as we approach this next wave. This approval granted by the Drug Control Authority in Malaysia means Avigan® being available nationally is a welcomed development at a time where the infection rates in Malaysia are increasing daily.”
Avigan® was first approved in Japan in 2014 as an influenza antiviral drug. It has generally been used 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, local regulatory authorities and prescribers, Avigan® can be provided to patients diagnosed with COVID-19 on a compassionate-use basis for emergency treatment outside of ongoing clinical studies in advance of regulatory approval in a given country.
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