E-DRUG: WHO provides first-ever approval for rectal artesunate for severe malaria
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Dear all,
We have exciting news to share with you: WHO has provided the first-ever prequalification for a rectal artesunate product for severe malaria. This approval will expand access to rectal artesunate and help save more young lives from malaria during that critical journey between a rural community setting and an appropriately equipped treatment centre.
Please find the press release copied below.
Let us know if you have any questions.
Best wishes,
Lizzie
PRESS RELEASE
WHO provides first-ever approval for rectal artesunate product for severe malaria
MMV collaboration helps make life-saving intervention more widely available
Geneva, 27 February 2018. On 22 February 2018, Indian pharmaceutical company Cipla Ltd. received confirmation of approval from the World Health Organization (WHO) Prequalification Programme for their 100mg rectal artesunate suppositories (RAS) for the pre-referral management of severe malaria. The much-awaited approval, achieved with support from MMV and funding from Unitaid, makes the Cipla product the first to receive prequalification for this indication. Importantly, prequalification will enable countries to procure life-saving RAS, thus ensuring the product's greater uptake and distribution.
"This is an important milestone," said Dr David Reddy, CEO of MMV. "This approval from the WHO prequalification programme will expand access to RAS and help save more young lives from malaria during that critical journey between a rural community setting and an appropriately equipped treatment centre. We are proud to have worked closely with WHO TDR, Unitaid, WHO's Global Malaria Programme and Cipla to reach this important moment. It's a true testament to the power of partnerships. Now that we have this international quality approval in place for RAS, we will continue the work with all stakeholders to support its introduction and availability into remote health settings to help save the lives of young children suffering from severe malaria."
Severe malaria can kill within 24 hours if left untreated, and travel times to hospital can be long, particularly for children from remote rural communities. WHO TDR's 2009 study demonstrated that a single dose of RAS 100mg, given as soon as a presumptive diagnosis of severe malaria has been made[1], can halve the likelihood of disability and death for young patients unable to access WHO-preferred first-line treatment for severe malaria, injectable artesunate (Inj AS), within 6 hours.[2] After receiving RAS, patients should be referred to a facility where they can receive Inj AS to treat their malaria infection.
In 2005, WHO first recommended the use of RAS for pre-referral management of young children with severe malaria. Until now, no RAS product has met international quality standards, leaving countries with limited options to cope with children in need of pre-referral care.
To bridge this gap, MMV worked with Cipla to obtain WHO prequalification for their RAS 100mg products. Cipla received a temporary authorization for one year from the Global Fund Expert Review Panel in 2016, allowing its product to be procured with donor funds.
"We have together achieved a major breakthrough by bringing together partners to secure WHO prequalification for a game-changing rectal artesunate product," said Unitaid's Executive Director, Lelio Marmora. "We now have a formidable weapon in our armoury that has the potential, once fully deployed, to sharply reduce the number of children under five succumbing to severe malaria."
To date, Cipla has registered RAS 100 mg in two high-burden countries and the dossier is under review in a further 14 countries. Close to 150,000 treatments have been distributed to countries by the company. For 2018, orders for RAS 100 mg have been placed to supply close to a dozen high-burden malaria countries.
Notes for editors
About malaria and children
Malaria places a heavy burden on the health of children. With intensive global effort, it is estimated that 6.2 million deaths due to malaria were prevented between 2001 and 2015; 5.9 million (95%) of which were those of young children. However, malaria continues to take its toll. In 2016, the disease took the lives of over 300,000 children under the age of 5 years. The launch of WHO pre-qualified RAS 100mg will make available a critical, quality pre-referral intervention that will help save many more young lives.
About WHO prequalification
Prequalification is a service provided by WHO to assess the quality, safety and efficacy of medicines. Every year, billions of US dollars' worth of medicines are purchased by international procurement agencies for distribution in resource-limited countries. Prequalification gives these agencies the choice of a wide range of quality-assured medicines for bulk purchase.
About Cipla Ltd.
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. In the last 80+ years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 80 countries. Our portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.
Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla's emphasis on access for patients was recognised globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001. Cipla's research and development focuses on developing innovative products and drug delivery systems.
About Unitaid
Unitaid is an international organisation that invests in new ways to prevent, diagnose and treat HIV and AIDS, tuberculosis and malaria more quickly, more cheaply and more effectively. We also work to improve access to diagnostics and treatment for HIV co-infection including hepatitis C. Unitaid researches and identifies new health solutions with potential to alleviate the burden of HIV and AIDS, tuberculosis and malaria, as well as HIV co-infections including hepatitis C. Through calls for proposals, Unitaid finds partners best qualified to put key innovations into practice who then receive grants from Unitaid to fast-track access and reduce costs of more effective medicines, technologies and systems.
About Medicines for Malaria Venture (MMV)
MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.
For details see
Elizabeth Poll | Medicines for Malaria Venture
Communications Manager
Elizabeth Poll <polle@mmv.org>