Investigational Multi-Drug Resistant Tuberculosis drug Bedaquiline gets backing from FDA panel

Johnson & Johnson said that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) ruled that its experimental treatment for multidrug-resistant tuberculosis appears to be safe and effective, according to a company news release Nov. 28.

Image/CDC

The FDA panel in a unanimous vote (18-0), agreed that the efficacy findings for  investigational bedaquiline support the proposed indication for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The committee agreed in a vote of 11-7 that the safety findings supported the proposed indication.

The FDA is not required to follow the panel’s advice, though it often does.

Wim Parys, Global Head of Development, Infectious Diseases and Vaccines, Janssen said, “We are pleased with the committee’s recommendation and look forward to working with the FDA to bring this important therapy to patients who suffer from MDR-TB.

“The positive recommendation from the FDA advisory committee is an important step toward achieving that goal.”

The FDA has agreed to evaluate the drug under its priority review system, which aims to decide whether to approve an application within six months, rather than the standard 10 months.

Bedaquiline would be the first drug specifically for multidrug-resistant tuberculosis, and the first new type of TB drug in more than four decades, according to a CNBC report.

Read more about Multidrug-Resistant Tuberculosis (MDR TB)

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