Regulator waives off clinical trials, clears Sanofi TB drug

NEW DELHI: India’s drug regulator has approved Sanofi (India)’s new anti-tuberculosis drug rifapentine, waiving local clinical trials in a move to bolster efforts to prevent latent infections from progressing into active TB.

“We have recently received final approval for rifapentine from the Indian regulatory authorities. Rifapentine is now officially registered in India,” Thibaud Lefort, Sanofi’s global health business chief, told ET on the sidelines of the 50th Union World Conference of Lung Health in Hyderabad.

While India carries the highest burden of TB with an estimated 2.69 million cases in 2018, more alarming is the possibility of a large pool of people harbouring the ‘silent infection.’ About 40% of the country’s population is estimated to have latent TB infection.

The waiver granted to Sanofi’s rifapentine, which is sold under the brand Priftin, is in the public interest, with a restricted marketing licence to supply the drug only for the government-run national TB programme.

Sanofi is now in talks with the government on the price of the drug, following its decision on Thursday to slash the price by 66%. The agreement brings rifapentine 150 mg tablets down to a price of €4.62/pack of 24 tablets (?364) from €13.60/pack of 24 tablets. Rifapentine is critical in preventing TB from developing and the lower price will benefit over a million people in India, experts said.

“What we need is to finalise the local price. We are in active discussion with the government authorities to finalise the price, taking into account the same discount. We are hopeful that by the first half of 2020 we should see Indian patients receiving rifapentine,” Lefort said.

The company will be required to conduct Phase IV trials in India, conducted after the medicine is made available to help identify any unforeseen side effects on patients. The once-weekly rifapentine 150 mg pills are found to be effective in cutting short the TB drug regimen by three months. Previously, preventive TB therapy took six to 36 months. A rifapentine-based regimen shortens the treatment to 12 weekly doses.

According to the latest World Health Organisation report, TB is the leading cause of death from infectious disease worldwide, killing 1.5 million people a year.