Johnson & Johnson has filed for approval in the US for bedaquiline, the first new type of medicine for tuberculosis in more than four decades and the first specifically developed for multi-drug-resistant (MDR) forms of the disease.
The New Drug Application (NDA) is seeking accelerated approval for the use of the bedaquiline (TMC207) as part of combination therapy for pulmonary MDR-TB in adults, which ranks as the number two killer of adults among infectious diseases worldwide.
Bedaquiline was discovered at J&J subsidiary Janssen Research & Development and works by inhibiting the proton pump of Mycobacterium tuberculosis - ATP synthase - a different mechanism to current TB drugs such as quinolone antibiotics which inhibit DNA gyrase.
"The emergence of multi-drug resistant strains of TB … is posing a significant new treatment challenge in controlling this serious and deadly disease," commented J&J's chairman of pharmaceuticals Paul Stoffels.
TB kills approximately 1.4 million people per year and current therapies do not provide adequate control of resistant strains, he added. Around 650,000 cases of MDR-TB were reported to the World Health Organization in 2010.
J&J is seeking approval for bedaquiline based on the results of two phase II studies carried out in patients with MDR-TB, and has already committed to a phase III trial comparing nine months of treatment with bedaquiline to placebo - on top of background therapy - that will get underway later this year.
Approval under the accelerated procedure could also provide J&J with a priority review voucher (PRV) under the FDA's scheme for rewarding companies which invest in the development of therapies for rare or neglected diseases.
The PRV would allow J&J to request priority review for another of its marketing applications. J&J was the first company to make use of a PRV after being awarded one for the approval of its antimalarial treatment Coartem (artemether/lumefantrine) in 2009.