Sanofi (India) is likely to be granted marketing authorisation for its new anti-tuberculosis medicine rifapentine, without the requirement of local clinical trials in India.
The Subject Experts Committee (SEC) for Antimicrobials & Antivirals has reportedly recommended the Central Drugs Standard Control Organization (CDSCO) to grant conditional approval to import and market the drug. CDSCO is the top drug regulator in India.
Rifapentine, however, should be available only through the National TB Control Program for the treatment of LTBI.
It is also required that the company conduct phase IV clinical trial on the drug. A drug surveillance programme, for which a protocol should be developed in consultation with the programme expert and submitted to CDSCO for review through SEC, should also be in place.
Rifapentine, which is sold under the brand name Priftin, is used in the treatment of latent tuberculosis infection (LTBI). The once-weekly rifapentine 150 mg pills are found to be effective 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 2015. The goal is to end the country’s number one infectious killer five years ahead of the global target of 2030.