J&J's (JNJ) Janssen Receives FDA Panel Backing for MDR-TB Drug Bedaquiline
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Janssen Research & Development, LLC (Janssen) today announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), 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.
"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," said Wim Parys, Global Head of Development, Infectious Diseases and Vaccines, Janssen. "The positive recommendation from the FDA advisory committee is an important step toward achieving that goal."
The FDA assigned a Priority Review designation to the New Drug Application (NDA) filed by Janssen in June seeking accelerated approval for bedaquiline. Recommendations and findings from the advisory committee will be considered by the FDA in its review of the NDA for bedaquiline, but the FDA is not bound to follow them.
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"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," said Wim Parys, Global Head of Development, Infectious Diseases and Vaccines, Janssen. "The positive recommendation from the FDA advisory committee is an important step toward achieving that goal."
The FDA assigned a Priority Review designation to the New Drug Application (NDA) filed by Janssen in June seeking accelerated approval for bedaquiline. Recommendations and findings from the advisory committee will be considered by the FDA in its review of the NDA for bedaquiline, but the FDA is not bound to follow them.
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