Johnson & Johnson has secured approval in Europe for Sirturo, one of the first new classes of tuberculosis (TB) therapy to reach the EU market in decades.
The EC has granted a license for Sirturo (bedaquiline) as part of a combination regimen for pulmonary multidrug resistant (MDR) TB, an orphan indication that affects around two out of every 10,000 people in the EU.
The approval has been given on the back of a phase II trial and is conditional upon J&J’s Janssen-Cilag subsidiary carrying out a phase III trial to confirm the risks and benefits of the drug.
Sirturo was approved in the US towards the end of 2012, and is a major scientific advance for TB as it is the first drug that inhibits mycobacterial ATP synthase, an enzyme that is essential for the generation of energy in Mycobacterium tuberculosis.
Sales are not expected to be massive for J&J as the drug is reserved for use in patients who cannot tolerate other drugs or are infected with a resistant strain of the organism, but could reach around $300m worldwide at peak according to analysts.
The drug’s importance from a public health standpoint cannot however be overstated, despite a rare cardiovascular side effect (QT prolongation) that requires a warning on its label.
“MDR-TB is associated with a high mortality rate and poses a significant public-health threat, as individuals infected with drug-resistant strains are often unable to receive adequate treatment and can potentially spread their infection,” commented Prof Martin Grobusch, who heads the Center for Tropical Medicine and Travel Medicine at the University of Amsterdam.
The approval of bedaquiline “is a critical step forward in tackling this rapidly growing disease and speeding up patient access to much needed treatment,” he added.
While wholly novel drugs to treat multidrug-resistant TB have been thin on the ground, last year saw a brace of new therapies approved in the EU, namely Otsuka’s Deltyba (delamanid), which was given a conditional approval last November along with Lucane Pharma SA’s para-aminosalicylic acid.
In recent years, the burden of TB resistant to first-line therapy of at least isoniazid and rifampicin, the two major anti-tubercular treatments, has increased rapidly in the absence of new treatment options.
