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This change compared to the earlier recommendation from 2006, reflects the new clinical evidence of this combination that has demonstrated similar efficacy and safety profile compared to existing ACTs.
Experts told Daily Sun that the new recommendation is an important step for physicians in Africa who now have an additional weapon in their fight against the disease.
The official nod by WHO has opened a new vista for Mepha Limietd, a generic manufacturer in Switzerland whose combination of artesunate and mefloquine used in their brand drug Artequin™ and Artequin™ Paediatric is now recommended by WHO for Africa.
“Mepha is proud of this change as it is the result of the considerable investment in research and development and the favourable outcome of several clinical trials conducted in Africa,” the company stated on their website.
“It is also an important step forward for Mepha as it reflects the considerable investments in research and development in this field. With Artequin and Artequin Paediatric (the first fixed-dose combination for children) Mepha has conducted clinical studies in several African countries, including Nigeria, with the aim to prove the safety and efficacy of this combination, especially in African children.”
One of the critical factors that influenced its recommendation by the WHO, besides its efficacy is the high safety profile, which was backed by the array of clinical trials carried out in Nigeria as well as other African countries.
In Nigeria, the drug was evaluated in Lagos, Jos, Maiduguri and Calabar, according to Mr. Clifford Nzimako, Managing Director, Occulus Pharmacare Limited.
“Over 20 years ago, Mepha decided to invest in research and development for new drugs to fight against this deadly disease. The goal was to find new and highly effective drugs for prophylaxis and treatment of malaria. These products needed to fit with our high Swiss quality standards but should as well, be affordable. Over the years, Mepha built up a leading role in this area with some innovative products,” Nzimako said.
“Based on new recommendations of the WHO, Mepha started the development of a combination therapy. In 2002, our ACT Artequin™ was launched for the treatment of uncomplicated malaria.
“It combines the two substances – artesunate and mefloquine in separate tablets. These tablets are packed in a patient-friendly three-colour blister to facilitate the daily administration of Artequin™. Treatment with Artequin™ allows a simple and highly effective therapy. Different dosage forms for adults and children are available in many African and Asian countries.
“One of the most important steps for Mepha was the launch of a specific fixed-dose combination for children: With an innovative technology, a mixture of pellets (similar to a powder) with artesunate and mefloquine, Artequin™ Paediatric has been developed. This exactly dosed mixture of pellets with a pleasant mango flavour is packed in stick packs such that each stick pack corresponds to a once-daily treatment dose and can be directly applied into the mouth of the child. A total of three stick packs used over three days leads to a fast and complete cure. And a big advantage: There is no water needed for the application of these pellets, which is a significant advantage, especially in Africa.
The WHO released new guidelines for the treatment of malaria, and the first ever guidance on procuring safe and efficacious anti-malarial medicines, last month.
In recent years, a new type of treatment called artemisinin-based combination therapy (ACTs) has transformed the treatment of malaria, but if not used properly the medicine could become ineffective.
The new guidelines provide evidence-based and current recommendations for countries on malaria diagnosis and treatment.
The main changes from the first edition of the guidelines (published in 2006) are the emphasis on testing before treating and the addition of a new ACT to the list of recommended treatments. WHO estimates that 80 countries have adopted ACTs for first-line treatment of uncomplicated P. falciparum malaria. In the guidelines, WHO emphasises the importance of treating this deadliest form of the disease with ACTs.
Half of the world’s population is at risk from malaria. Each year, almost 250 million cases occur, causing 860,000 deaths. Approximately 85 per cent of these deaths are among children, and most occur in Africa.
“It is critical that artemisinins be used correctly,” said Dr. Lee Jong-wook, WHO’s Director-General. “We request pharmaceutical companies to immediately stop marketing single-drug artemisinin tablets and instead market artemisinin combination therapies only. The new treatment guidelines we are releasing today provide countries with clear and evidence-based direction on the best treatment options for malaria.”
According to the new guidelines, uncomplicated falciparum malaria must be treated with ACTs and not by artemisinin alone or any other monotherapy because the use of single-drug artemisinin treatment, or monotherapy, hastens development of resistance by weakening but not killing the parasite.
“So far, no treatment failures due to artemisinin drug resistance have been documented, but we are watching the situation very attentively,” said Dr. Arata Kochi, the newly appointed director of WHO’s malaria department.
