Mylan Gets Expert Panel Go-Ahead For Pretomanid In India
Tuberculosis drug pretomanid gets endorsement, with Phase III trial waiver, from a key expert panel that advises India's drugs regulator, but roll out plan needs to be defined under the country’s national TB program, say health activists.
You may also be interested in...
South Korea’s Qurient achieves proof of concept in a Phase II study with its first-in-class antibiotic telacebec for tuberculosis and aims to file a US NDA for the orphan drug.
Price cuts, new treatments for TB and alliances to improve access to these medicines were among the key talking points at the recently concluded Union World Conference on Lung Health in India. TB survivors and activists were also vocal and pressed hard for their demands to be heard.
US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.