Sanofi TB Drug In India
Sanofi is likely to be granted marketing authorization for its new anti-tuberculosis medicine rifapentine India soon.
The Subject Experts Committee (SEC) for Antimicrobials & Antivirals has reportedly recommended CDSCO to grant conditional approval to import and market rifapentine. The Central Drugs Standard Control Organization is the primary drug regulator in India.
Rifapentine, however, should be available only through the National TB Control Program for the Treatment of Latent Tuberculosis Infection (LTBI). It is also required that the company conduct a phase IV clinical trial on the drug. The drug surveillance program, for which protocol should be developed in consultation with the program expert and submitted to CDSCO for review through the SEC.
Sanofi TB Drug In India- Which Is The New Drug?
Rifapentine is sold under the brand name Priftin. It is used in the treatment of LTBI. The once-weekly rifapentine 150 mg pills are found to be useful to cut short the TB drug regimen by three months.
Unlike the active disease, LTBI shows no outward symptoms; hence, it is often left undiagnosed. The proportion of LTBI is estimated at around 40% in India, which is far higher than the world average.
India has set an ambitious target of eliminating TB by 2025. The goal is ending the country’s number one infectious killer five years ahead of the global target of 2030.
Author: Rahul Mishra