ArTiMist® was designed with a child in mind; a child living in a challenging environment where healthcare resources can be very scarce and time is of the essence. ArTiMist is the world’s first sub-lingual spray for the treatment of p. falciparum severe paediatric malaria. The active pharmaceutical ingredient in ArTiMist is artemether, which is a widely used anti-malarial and is currently administered by intra muscular injection or orally in a tablet form.
In 2011, ArTiMist was identified by Thompson Reuters as one of the World’s 5 most promising drugs in Phase III clinical development. Its intrinsic characteristics (efficacy, user-and-patient friendly, hygienic and non-toxic) could make ArTiMist the treatment of choice in urban and in rural locations.
In brief, the benefits of ArTiMist include:
- was designed with a child in mind; a child living in a challenging environment where healthcare resources can be very scarce and time is of the essence.
- is the world’s first sub-lingual spray for the treatment of P. falciparum severe paediatric malaria.
- is administered sub-lingually, enters the bloodstream and attacks the parasite.
- is especially effective in the treatment of children and young infants who are experiencing malaria-related gastro-intestinal problems and cannot tolerate oral treatments.
In summary, ArTiMist addresses a major unmet medical need in the paediatric treatment of severe malaria and uncomplicated malaria with GI complications. It also directly addresses the WHO requirement to provide a novel solution to minimise treatment delays to reduce morbidity.
In May 2019, SUDA received the official Delegate’s letter of denial for the marketing approval of its ArTiMist oral spray. SUDA subsequently lodged an appeal under Section 60 of the Therapeutic Goods Act of 1989 in August 2019. The outcome of the appeal was that the Ministers Delegate upheld the original decision to deny the approval of ArTiMist.
During the review the three key sections of the application covering the Pre-clinical, Clinical and Chemistry Manufacturing and Control aspects of the application were reviewed in detail. These sections cover the quality, safety and efficacy of the proposed drug product. All sections were reviewed by the appropriate sections within the TGA and the reviewer, based on the information provided and reviewed, recommended the product for approval.
The reason for the decision was stated as; “that the Delegate was not satisfied that the safety and efficacy of the product had been satisfactorily established for the purpose for which it is intended for use.”
A key recurring reason that appears throughout the decision document was that the Delegate had concerns with regard the use of an artemisinin monotherapy and the potential of misuse or abuse that may result in the formation of artemisinin resistance. The Delegate believes that this results in “an overall negative benefit to risk profile for ArTiMist.”
The Delegate was further concerned that due to the low level of adherence to current treatment guidelines in malarial endemic areas, the ease of use of ArTiMist and the number of doses in a vial, could lead to further non-compliance to treatment guidelines that may result in the occurrence of further resistance.
The Board continues to assess alternatives for the ArTiMist project.