I believe the may be flogging a dead horse. At this stage Artimist is dead in the water and unlikely to be resuscitated. The company should write it off and move on. Their only hope is to claim it as a tax write off to recover some of the costs. With the WHO organization, the writing was on the wall a long time ago. I believe a lot of people got sucked into the hype, myself included. No major company has been prepared to put an offer on the table for over 10 year which should have told people something. Now the TGA has spelt it out in plain English for all to see and understand. The TGA position supports what the WHO has stated over ten years ago.
Withdrawal of oral artemisinin-based monotherapies
Last update: 24 October 2017
The continued use of oral artemisinin-based monotherapies is considered to be a major contributing factor to the development of resistance to artemisinin derivatives. WHO urges regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies, and promote access to quality-assured artemisinin-based combination therapies (ACTs).
ACTs are the mainstay of recommended antimalaria treatments today, and their efficacy must be preserved, as no new class of antimalarial medicines is expected to enter the market within the next few years.
World Health Assembly resolution
In 2007, WHO Member States adopted World Health Assembly resolution WHA60.18 which calls for a progressive removal of oral artemisinin-based monotherapies from markets. Oral monotherapies need to be withdrawn from all pharmacies and health clinics around the world. Only rectal formulations for pre-referral treatment and injectable formulations for the management of severe malaria should be deployed, as combination treatments do not yet exist for the management of severe malaria.
The WHO Global Malaria Programme has been monitoring the positions of manufacturing companies and national regulatory authorities in relation to the production and marketing of oral artemisinin-based monotherapies.
A strengthening of pharmaceutical regulation and the enforcement of existing regulations is needed to ensure complete withdrawal of oral artemisinin-based monotherapies from all countries. The latest information on the positions of countries and manufacturers regarding the marketing of these products is available in the below documents.
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