On June 19, 2018, Strides Shasun announced the receipt of prequalification from the World Health Organization (WHO) for their 100mg Rectal Artesunate Suppositories (RAS) for the pre-referral management of severe malaria8. This prequalification enables countries to procure life-saving RAS with donor funding, thus ensuring increased access to this potentially life-saving intervention. This prequalification is achieved with support from Medicines for Malaria Venture (MMV) and funding from UNITAID, an international organization that invests in innovations to prevent, diagnose and treat HIV/AIDS, tuberculosis and malaria quickly, affordably and effectively.

Severe malaria is a medical emergency which can kill within 24 hours, if left untreated (particularly cerebral malaria), 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, can halve the likelihood of disability and death or young patients unable to access WHO-preferred first-line treatment for severe malaria which is injectable artesunate (Inj AS), within 6 hours. After receiving RAS, patients should be referred to a facility where they can receive Injection AS to treat the severe malaria infection, followed by a course of artemisinin combination treatment when they are able to take oral medication9.

About Rectal Artesunate Suppositories

Rectal Artesunate Suppositories 100 mg is available in the form of soft capsule. In 2005, WHO first recommended the use of RAS for pre-referral management of young children with severe malaria. Until 2018, no RAS product had 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.

About Malaria

Malaria is a life-threatening disease caused by parasites transmitted to people through the bites of infected female Anopheles mosquitoes, called "malaria vectors". There are 5 parasite species that cause malaria in humans, and 2 of these species – P. falciparum and P. vivax – pose the greatest threat.

  • P. falciparum is the most prevalent malarial parasite on the African continent. It is responsible for most malaria-related deaths globally.
  • P. vivax is the dominant malarial parasite in most countries outside of sub-Saharan Africa.

According to WHO's 2016 report on Malaria, there were 212 million new cases of malaria worldwide in 2015 (range 148–304 million). The WHO African Region accounted for most global cases of malaria (90%), followed by the South-East Asia Region (7%) and the Eastern Mediterranean Region (2%). In 2015, there were an estimated 429,000 malaria deaths (range 235,000–639,000) worldwide. Most of these deaths occurred in the African Region (92%), followed by the South-East Asia Region (6%) and the Eastern Mediterranean Region (2%)10.

About WHO pre-qualification

WHO prequalification aims to ensure that diagnostics, medicines, vaccines and immunization-related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy, in order to optimize use of health resources and improve health outcomes. The prequalification process consists of a transparent, scientifically sound assessment, which includes dossier review, consistency testing or performance evaluation and site visits to manufacturers11.

Footnotes

8. https://extranet.who.int/prequal/medicine/3890

9. http://www.stridesarco.com/pdf/pressrelease/2018/press_release_20180621.pdf

10. http://www.who.int/malaria/media/world-malaria-report-2016/en/

11. http://www.who.int/topics/prequalification/en/

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