By Nathalie Tadena
The Food and Drug Administration has granted accelerated approval for Johnson & Johnson's (JNJ) drug to treat a drug-resistant form of tuberculosis.
The drug, bedaquiline, has faced concerns about an imbalance of deaths seen in clinical studies. J&J's Janssen Research & Development had asked the FDA for accelerated approval of bedaquiline, which is a type of temporary approval based on less clinical data than required for traditional drug approvals.
The accelerated approval was based on data from a pair of Phase 2 studies--one of which showed 77.6% of patients in the treatment group reaching treatment success after 24 weeks compared with 57.6% of those in the placebo group--but the prescribing information for the treatment will include boxed warnings regarding increased risk of death.
Last month, an FDA panel supported a type of early approval for J&J's experimental drug; however, panel members were divided on whether bedaquiline played a role in deaths seen in clinical studies. While the FDA has said the safety data currently available for bedaquiline suggest the product appears safe, there is a potential for the highest dose of the product to cause a small change in the heart's rhythm. The FDA had said there wasn't enough data to rule out potential drug side effects on the liver and the heart. There were more deaths seen among patients being treated with bedaquiline although most of the deaths were attributed to the underlying disease.
The consumer group Public Citizen has strongly opposed the accelerated approval of bedaquiline because clinical trials showed the drug could be highly dangerous.
Only about 100 cases of drug-resistant TB are seen each year in the U.S. but the problem is more severe in typically poor countries outside the U.S.
Tuberculosis is a bacterial infection that mostly involves the lungs. It is treated with a combination of four drugs for at least six months, according to the National Heart, Lung and Blood Institute. Bedaquiline is designed to work in a new way to treat TB and would be used with other drugs.
However, there is evidence that some forms of TB can't be treated with currently available drugs, which the FDA has said "threatens to erode the progress made in the worldwide control of tuberculosis."
Tuberculosis can be fatal if it's not properly treated.
Write to Nathalie Tadena at [email protected]
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