アメリカ合衆国の薬剤機関(食品医薬品局)は、抗生物質のリファンピシナ(Rifampicina)、イソニアジダ(Isoniazida)の薬剤耐性の結核のために開発された初めての薬剤ベダキリナ(Bedaquilina)を
承認
EE UU aprueba el primer fármaco contra la tuberculosis resistente
La OMS calcula que hasta 300.000 personas tuvieron esta agresiva forma de la enfermedad en 2011
Emilio de Benito Madrid 2 ENE 2013 - 13:50 CET
U.S. approves first drug-resistant tuberculosis
WHO estimates that up to 300,000 people took this aggressive form of the disease in 2011
Emilio de Benito Madrid 2 ENE 2013 - 13:50 CET
The drug agency USA (Food and Drug Administration) approved on 28 December a new drug against tuberculosis (and announced on 31 December). This is the bedaquilina, and its special feature is the first drug specifically indicated for resistant forms of infectious disease.
Mutations of the bacillus are so important that you define a new type of tuberculosis: the multi-resistant (MDR), defined as the microorganism is not responding to two of the most common drugs, rifampicin and isoniazid. So the only option is to try more aggressive combinations that can be up to two years with 20 pills a day, a regime that in many countries is unsustainable. The severity of this variant is increasing. The World Health Organization (WHO) estimates that in 2011 there were 8.7 million cases of tuberculosis worldwide, of which 1.4 million people died. WHO estimates indicate that there have been more than 300,000 cases of the resistant variant, and only 20% receive treatment.
moreScientists find "alarming" levels of resistant tuberculosisThe WHO warns of the rise of drug-resistant tuberculosis in the European
In fact, the FDA has approved the drug under an accelerated procedure, which is used to reduce time and is based on a rapid assessment of the risk of the drug against the potential benefits. Therefore indicates that the drug should be used in combination with others, and has several risks, especially heart.
Despite this, and because of the severity of the infection, organizations such as Doctors Without Borders (MSF) have greeted the news with joy. "The is the first drug bedaquilina active TB the FDA approves since 1963", indicated in a statement. "It's an egregious advance, and also the fact that this drug is active against drug-resistant forms of TB is that it has the potential to change the rules of the game," said the director of MSF's Campaign for Access, Dr. Manica Balasegaram.
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