ArtecapTM

Strides Pharma

Product category
  • Artesunate suppositories

Therapeutic indication
  • Pre-referral emergency intervention for severe P. falciparum malaria in children aged 6 months* (5kg) to 6 years (20kg) 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 immediately by referral to health facility able to administer parenteral treatment

Efficacy
  • Halves death and disability in the target population
Key features
  • Addresses key unmet medical need 

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

  • Obtaining switch by countries, currently procuring non-quality assured product to WHO pre-qualified 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 11 malaria-endemic countries (see map)
Next milestone
  • Ongoing country registrations and deliveries

Previously
  • WHO TDR completed Phase lll trials 

MMV Project Director
  • Hans Rietveld