Janssen Therapeutics, Division
of Janssen Products, LP, today announced the U.S. Food and Drug Administration
(FDA) has granted accelerated approval to SIRTURO™ (bedaquiline) Tablets for
the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part
of combination therapy in adults. The accelerated approval is based on the
surrogate endpoint of time to sputum culture conversion.
"SIRTURO™ was first discovered in our laboratories more than a decade ago and
it is gratifying to see our discovery and development lead to the accelerated
approval of the first TB therapy in 40 years with a new mechanism of action.
This underscores our commitment as a company to discover, develop and
responsibly deliver innovative medicines that address serious unmet medical
needs," said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide
Chairman, Pharmaceuticals, Johnson & Johnson.
SIRTURO™ inhibits mycobacterial ATP (adenosine 5'‑triphosphate) synthase, an
enzyme that is essential for the generation of energy in Mycobacterium
tuberculosis.
SIRTURO™ is a diarylquinoline antimycobacterial drug indicated as part of
combination therapy in adults (greater than or equal to 18 years) with
pulmonary MDR-TB. Reserve SIRTURO™ for use when an effective treatment regimen
cannot otherwise be provided. SIRTURO™ should be administered by directly
observed therapy (DOT). This indication is based on analysis of time to sputum
culture conversion from two controlled Phase 2 trials in patients with
pulmonary MDR-TB. The safety and efficacy of SIRTURO™ for the treatment of
latent infection due to Mycobacterium tuberculosis has not been established.
The safety and efficacy of SIRTURO™ for the treatment of drug-sensitive TB has
not been established. In addition, there are no data on the treatment with
SIRTURO™ of extra-pulmonary TB (e.g., central nervous system). Therefore, use
of SIRTURO™ in these settings is not recommended.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in