GRA, Dr. Reddy’s Laboratories to make Avigan available in Malaysia
Global Response Aid (GRA), part of the Agility group, 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 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.
Avigan was developed by FujiFilm Toyama Chemical 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 have 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 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 defense 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 in the near future and will be announcing multiple manufacturing locations to meet the growing global demand.”
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 Malalysia means Avigan being available nationally is a welcomed development at a time where the infection rates in Malysian are increasing daily.”