There was much cheer earlier this month when the USFDA  approved pretomanid to treat some stubborn drug-resistant forms of tuberculosis . After all, the significance of having a drug that can reduce the treatment timeline and address the drug resistance issue cannot be over-emphasised.

Pretomanid is the third new drug developed for TB in over half a century, after bedaquiline and delaminid. It is a novel compound developed by non-profit organisation TB Alliance that has a collaboration with Mylan to commercialise the drug.

The new drug is part of a three-drug (bedaquiline, pretomanid and linezolid), six-month, all-oral regimen for the treatment of people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.

Tempering the optimism

But optimism over the drug is being tempered with caution, as concerns emerge on registering pretomanid, the logistics of rolling out a three-drug combination, their individual safety features and its price in high-disease regions such as India.

Registering pretomanid could be a challenge as the data dossiers are clubbed together, said Leena Menghaney, who works for Access Campaign, part of international humanitarian organisation Médecins Sans Frontières. While patients will be happy with a shorter regimen, the three-drug system does not make procurement for the government any simpler, she said. Besides, this could also complicate patient compliance to the medication regimen.

Now, the government gives bedaquiline, sourced from Johnson and Johnson’s pharma arm Janssen, free of cost to TB patients. But this free programme ended in March.

“TB drugs come fraught with conditions,” said Menghaney, pointing out that the initial registration of bedaquiline was for conditional access.

Addressing concerns on registration, a Mylan spokesperson told BusinessLine : “Pretomanid will be available from Mylan, which will have the responsibility for registration. Bedaquiline is available from Janssen, which has associated responsibility for registration. Linezolid is available from multiple manufacturers, each of which retains independent responsibility to register its product.”

Pricing issues

On pricing concerns, she said: “In low- and lower-middle-income countries, we have not yet announced our launch price, in part because pricing discussions with global procurement bodies were pending FDA approval. Now that it has been received, discussions can begin. With FDA approval, we also can begin pursuing national registrations in countries with a high burden of extensively drug-resistant TB, including India.”

Pointing to Mylan’s role in reducing drug prices, including an 80 per cent reduction in HIV treatment prices over the last decade, the spokesperson said: “Our licence agreement for pretomanid tablets is non-exclusive after November 2020 for 140 low- and middle-income countries, including India, where the drug-resistant TB burden is the highest .”

This reflects the company’s commitment to ensure affordable and sustainable access to new TB treatments from multiple sources, she added.

“As part of this, for those non-exclusive countries, we have committed in principle to providing to generic licensees of the TB Alliance necessary waivers and authorisations, the right of reference to Mylan’s approvals and to making product samples available,” she said.

Need for coordination

Madhukar Pai, Director of McGill TB Center, pointed out that much coordination would be required, not just from TB Alliance and Mylan, but the other stakeholders as well in rolling out the drug.

“If India is serious about making the six-month regimen available for its XDR-TB patients, it will need to get this regimen into drug trials and register both pretomanid and bedaquiline,” he said.

“The RNTCP (Revised National TB Control Programme) will have to negotiate the price, procure and deliver the drugs, and TB advocates in India must hold them accountable,” he added.