It can be a Revolution in treatment of Multidrug-Resistant Tuberculosis!
Multidrug-resistant tuberculosis (MDR TB) is caused by Mycobacterium tuberculosis
that is resistant to at least isoniazid and rifampin, the two most
effective of the four first-line TB drugs (the other two drugs being
ethambutol and pyrazinamide). MDR TB includes the subcategory of
extensively drug-resistant TB (XDR TB), which is MDR TB with additional
resistance to any fluoroquinolone and to at least one of three
injectable anti-TB drugs (i.e., kanamycin, capreomycin, or amikacin).
MDR TB is difficult to cure, requiring 18–24 months of treatment after
sputum culture conversion with a regimen that consists of four to six
medications with toxic side effects, and carries a mortality risk
greater than that of drug-susceptible TB.
Bedaquiline fumarate (Sirturo or bedaquiline) is an oral
diarylquinoline. On December 28, 2012, on the basis of data from two
Phase IIb trials (i.e., well-controlled trials to evaluate the efficacy
and safety of drugs in patients with a disease or condition to be
treated, diagnosed, or prevented), the Food and Drug Administration
(FDA) approved use of bedaquiline under the provisions of the
accelerated approval regulations for "serious or life-threatening
illnesses" (21CFR314.500) (Cox EM. FDA accelerated approval letter to
Janssen Research and Development.
