Avigan® Approved for COVID-19 Treatment in Malaysia
Global Response Aid and Dr. Reddys to make anti-virual available through government
DUBAI – December 7, 2020 – 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 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.”
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 Malalysia means Avigan® being available nationally is a welcomed development at a time where the infection rates in Malysian are increasing daily.”
Avigan® was first approved in Japan in 2014 as an influenza anti-viral 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.
About Avigan (Favipiravir)
Avigan (Favipiravir) an influenza anti-viral developed by FujiFilm, comes in tablet and IV form and is approved in a number of countries as a therapeutic to reduce the severity of COVID-19 symptoms and speed the recovery of patients diagnosed with the virus. Data is emerging from multiple clinical studies indicating its effectiveness in the treatment of mild to moderate COVID-19 patients. Therefore, it could serve a first line of treatment in patients long before severe symptoms set in, reducing the need for hospitalization. Avigan is currently being tested in an extensive array of clinical trials in co-ordination with the US FDA and EMA including a large study in Middle East and a total of five Phase 2 and 3 studies in the USA involving Stanford School of Medicine, Dr Reddy’s, Appili as well as the US DOD. Avigan is developed commercially through a joint venture between FuiFilm (Japan), Dr. Reddy Laboratories (NASDAQ: RDY) and GRA (a Dubai based company established by Agility (KSE: AGLTY).
About Global Response Aid (GRA)
Agility (KSE/DFM: AGLTY), one of the world’s leading logistics companies, established Global Response Aid (GRA) to address the market challenges created by the COVID-19 pandemic and other threats to public health. GRA delivers innovative, effective healthcare solutions through a range of pharmaceutical products and technology platforms. It works closely with governments, regulatory authorities, hospitals, clinics, healthcare providers, life sciences companies, NGOs and public institutions to develop strategies that allow them to tackle public health challenges.VISIT GLOBAL RESPONSE AID
About Dr. Reddy’s
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe.VISIT DR. REDDY'S
FUJIFILM Corporation, Tokyo, Japan is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship.VISIT FUJIFILM