Govt registers new dose of strengthened anti-malaria drug

BY GETRUDE MBAGO

22nd November 2015

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The Tanzania Foods and Drugs Authority (TFDA), has registered a new high dose for the leading anti malaria drug that has now been strengthened to enhance its effectiveness.

The refurbished drug was launched Friday evening the Dar es Salaam Registrar of the Pharmacy Council in Tanzania Elizabeth Shekalaghe, specifying that the high dose of Coartem® 80/480 (artemether/lumefantrine whose composition is 80 mg and 480 mg of either compound had been restructured.

The drug is accepted by the TFDA as first line anti-malaria drug, whose manufacturers constantly battle with resistant strains of malaria, and revising drug composition and dosage for higher effectiveness across wide ranges of affected populations.

The treatment is applicable for the treatment of malaria in adults and older children who weigh 35kg and above, launched by Novartis Co., a global pharmaceuticals group.

Manufacturers and experts at the function said the new dose has already been launched in Nigeria, Kenya and Angola, Ivory Coast and several other African countries.

The Dar es Salaam Registrar in her remarks emphasized the importance of rational use of medicine and creating awareness to the public on the changes in dose and application.

She urged a collaborative effort amongst the various stakeholders to ensure that medicines are used correctly.

The event was being done in other places and now Tanzania had also joined this increasing number of countries in launching the reformulated drug, she said.

She reminded the gathering that the drug is restricted to little babies so parents have to get a clear note on that limitation.

For his part, Dr. Nathan Mulure, the Novartis head of Africa operations said that malaria is highly preventable and curable, yet it is still one of the most deadly diseases in developing countries.

“Novartis reaffirms its strong commitment to the fight against malaria,” he said, saying the reformulated drug was a tuly remarkable milestone contributing to treating many patients and help in reducing the disease burden.

The fewer tablets offer a convenient solution for busy lives, the Novartis executive noted.

 According to him, in a bid to enhance patient compliance, the full course of treatment for malaria has been reduced from 24 tablets to six tablets translating into a 75% reduction in pill burden using Coartem 80/480.

He said the launch of Coartem® 80/480 in Tanzania marks another milestone in the fight against Malaria, and will benefit patients with a convenient and high quality treatment for malaria.

The Coartem 80/480 was first registered in Switzerland by a stringent health authority, the Swissmedic.

Novartis pioneered the launch of a fixed-dose ACT, and ten years later, in 2009, the first dispersible ACT was tailored to meet the needs of children who are the most vulnerable to malaria.

“Through a partnership with the World Health Organization (WHO) in 2001, we were the first company in the healthcare industry to commit to the supply of antimalarial treatments to the public sector in endemic countries without profit”, added Dr Mulure.

"Each year there are more than one million malaria-related deaths around the world. Nine out of ten malaria deaths occur in sub Saharan Africa, and the vast majority of malaria-related deaths occur in children.

In Africa alone, a child dies every 60 seconds from malaria," he noted
Dr Mulure added that as part of its ongoing commitment to patients and health workers, Novartis also provides malaria case management educational programs, which include hands-on training for local healthcare workers, customized training manuals, and user-friendly packaging to ensure that Coartem and Coartem Dispersible are properly used and to improve patient compliance.

In 2001, Novartis signed a memorandum of understanding with the World Health Organization to provide at no profit, Coartem to malaria endemic countries all over the world. Since then, Coartem has grown from 100,000 treatments per year product to over 100 million treatments, a milestone that was achieved in the year 2011.

Others who spoke during the launch include the renowned malariologist from Aghakhan University in Kenya Prof Zul Premji advised that malaria must be confirmed by laboratory or rapid diagnostic tests before treatment is started.

Novartis is the first company to develop a WHO prequalified child friendly medication, the Coartem Dispersible.  Dispersible tablets easily break up in water, are sweet and easy to take.

Two sites in Tanzania participated in the phase 3 clinical trials of Coartem Dispersible tablet. Since 2009, over 250 million dispersible tablet treatments have been delivered the vast majority to African countries.

SOURCE: GUARDIAN ON SUNDAY