ArtecapTM

Strides Pharma

Product category
  • Artesunate suppositories

Therapeutic indication
  • Pre-referral emergency intervention for severe P. falciparum malaria in children aged 6 months to 6 years and >6h from a treatment centre
Dosing
  • For ages 6 months to <3 years – 1 x 100mg suppository, 3 to 6 years - 2 x 100mg suppository

  • Administration should be followed as soon as possible by referral to health facility able to administer parenteral treatment

Efficacy
  • Halt progression of disease until patients with severe malaria reach a treatment centre

  • Halves death and disability in children ≤6 years of age affected by severe malaria and living >6 hours from a referral centre

Key features
  • Addresses key unmet medical need pre-referral intervention for severe malaria in children from 6 months to 6 years

Challenges
  • Requires close supervision and referral mechanisms to ensure correct use

  • Obtaining switch by countries, currently procuring non-quality assured product to WHO prequalified product

Status
  • WHO prequalifed in 2018

  • 100mg rectal artesunate included in WHO Essential Medicines List (April 2017 revision)

  • 1.5 million orders of rectal artesunate in 2018. 85% of orders placed by Global Fund, PMI and UNICEF for 2018 are for 100mg quality assured product

  • Product registered in 16 malaria-endemic countries (see map).
  • Implementation program in Zambia supported by MMV resulted in >95% reduction in the severe malaria case fatality rate

Next milestone
  • Ongoing country registrations and deliveries

Previously
  • WHO TDR completed Phase III trials 

MMV Project Director
  • Pierre Hugo