FDA OKs new treatment of highly drug-resistant TB licensed to Mylan

The FDA approves TB Alliance’s pretomanid, as part of a three-drug that includes bedaquiline and linezolid, for the treatment of extensively drug-resistant tuberculosis (TB).

Pretomanid, a compound called a nitroimidazooxazine, was approved under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) that is aimed at encouraging the development of antimicrobials for infections affecting small patient populations. It is only the third new chemical entity approved in the U.S. for TB in more than 40 years.

Commercial launch will commence by year-end by collaboration partner and licensee Mylan N.V. (MYL -8.6%).

https://seekingalpha.com/news/3491747-fda-oks-new-treatment-highly-drug-resistant-tb