Second producer of drug used to treat Chagas welcomed, but more R&D is urgently needed
Buenos Aires, 20 March 2012 — Medecins Sans Frontieres (MSF) has welcomed today’s announcement from Argentina’s Fundación Mundo Sano and the Argentinean Ministry of Health that it will shortly start production of benznidazole. Benznidazole, the main drug used in the treatment of Chagas, a neglected tropical disease endemic in Latin America, had until now only one producer worldwide, and faced difficulties of guaranteed supply. However, MSF also reiterates its call on governments of endemic countries to prioritize access to diagnosis and treatment for the estimated 8 to 10 million people affected by the disease.
Chagas programs across the continent currently depend on a single laboratory to produce benznidazole, the Brazilian public laboratory LAFEPE (Laboratorio Farmaceutico do Estado de Pernambuco). However, Fundación Mundo Sano, along with the pharmaceutical group Chemo, has developed a new generic version of the drug, to be manufactured by Argentinean laboratory Elea under the name Abarax, in 100mg and 50mg tablets. While initially the product will only be available in Argentina, Fundación Mundo Sano has expressed interest to produce it for other countries. Moreover, even if initially the drug was registered only for treatment of acute cases, it was recently reported that it will also make it available to treat chronic cases.
"Having a second producer of the drug is undoubtedly good news, and we welcome Mundo Sano Foundation for bringing this initiative forward," says Gemma Ortiz, Neglected Diseases Senior Advocacy Officer for MSF. "However, we are anxious to see details on its eventual availability in the rest of Latin America, the product’s price and projected production volumes, and the type of partnership distribution that they plan to establish with LAFEPE and PAHO (Pan American Health Organization).”
This announcement comes just as production of benznidazole is still in a state of vulnerability. In October 2011, a shortage of the drug and the threat of stock rupture forced MSF to suspend the opening of new Chagas projects in Bolivia, and to reduce its diagnosis of new patients in Paraguay over a period of time. To this day, supply still isn’t guaranteed in several countries, even after LAFEPE publicly committed to speed up benznidazole production and registration in the wake of MSF having called on the Brazilian Ministry of Health to do so and to implement other necessary regulatory steps. Until Fundación Mundo Sano and Chemo Group can make their supply available outside Argentina, LAFEPE is still the only producer for the rest of Latin America.
For decades, patients suffering from Chagas have been neglected. MSF, who has been working on Chagas projects since 1999 and currently has operations in high prevalence countries Bolivia and Paraguay, has been able to demonstrate that treatment is possible and safe, both in acute and chronic stages, if regular medical follow-up is provided. MSF has been advocating for years for the prioritization of diagnosis and treatment for patients. In recent years, demand for treatment has increased significantly because adults are now being treated as well as children. New medical evidence also showed the benefits of treatment with the drug for chronic stage patients. World Health Organization and PAHO have also strongly endorsed diagnosis and treatment at the primary healthcare level.
“While in this context the announcement of a new supplier of benznidazole is encouraging, we should not lose sight of the need to devote more effort to research and development of new drugs”, says Gemma Ortiz.
Both benznidazole and nifurtimox, the only drugs available to treat the disease, were developed over 40 years ago and, while manageable under medical supervision, they can also have side effects.
About Chagas disease
Chagas disease, also known as Human American Trypanosomiasis, is an infectious disease caused by the parasite Trypanosoma cruzi. Endemic in several Latin American countries, it causes 12,500 deaths per year and it is estimated that 8 to 10 million people have the disease. Case numbers are rising in the US, Europe, Australia and Japan as a result of greater international travel.
In most Latin American countries the disease is primarily transmitted through the contaminated faeces of the kissing bug or “vinchuca”, although it can also be transmitted from mother to child, in blood transfusions, organ transplants, contaminated food and laboratory accidents. Because the infection is usually asymptomatic, most patients are unaware that they have it. However, as the chronic stage of the disease progresses, around one third of those infected will develop heart, digestive, and/or brain lesions that may be fatal.
Until recently treatment was thought only to be effective in the acute stage (for up to three months after being infected) and very early chronic stage. However, studies have now shown that it can also be effective in the chronic stage. It has also been found in recent years that the side effects of the drug, which are more common in adults, are manageable and that under supervision, treatment is even feasible in primary healthcare.