Strides Shasun’s rectal artesunate product receives WHO prequalification

Strides Shasun’s rectal artesunate product receives WHO prequalification

On 20 June 2018, Strides Shasun Ltd., based in Bangalore, India, received prequalification from the World Health Organization (WHO) for their 100mg rectal artesunate suppositories (RAS) for the pre-referral management of severe malaria. Achieved with support from MMV and funding from Unitaid, this prequalification enables countries to procure life-saving RAS with donor funding, thus ensuring increased access to this potentially life-saving intervention.

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 severe malaria infection, followed by a course of artemisinin combination treatment when they are able to take an oral medicine.

In 2005, WHO first recommended the use of RAS for pre-referral management of young children with severe malaria. Until 2018, no RAS product has met international quality standards, leaving countries with limited options to cope with children in need of pre-referral care. WHO prequalification of the Strides’ product follows the approval of Cipla’s RAS product earlier this year.

“This second approval of a RAS product from the WHO prequalification programme will further expand access to this important life-saving intervention and help save more young lives from malaria,” said Dr David Reddy, CEO of MMV. “This has been a significant inter-organizational effort; we are proud to have worked closely with WHO TDR, Unitaid, WHO’s Global Malaria Programme and Strides to achieve it. The work now continues to ensure introduction and use of RAS where it is needed most in remote health settings.”

“We are honored to have collaborated with MMV and Unitaid on this project and to have now received WHO approval for our novel-delivery soft-gel artesunate suppositories for use in children suffering from severe malaria,” said Mr Arun Kumar Group CEO and MD of Strides Shasun Ltd. “We will now leverage our significant presence in Africa to register and distribute the product where needed on the continent. To this end, dossiers have already been submitted in 25 of the countries that could benefit most.”

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).