WHO provides first-ever approval for rectal artesunate product for severe malaria

WHO provides first-ever approval for rectal artesunate product for severe malaria

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 made1, 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.

Read the news on Unitaid's website.

1.  “Rectal artesunate for pre-referral treatment of severe malaria” WHO-GMP Information Note, October 2017

2. Gomes MF et al. “Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial.” Lancet. 14;373(9663):557-66 (2009).