US Approves New Antibiotic For Drug-Resistant Tuberculosis

Pretomanid is only the third new TB drug to be approved by the FDA in more than 40 years.

KUALA LUMPUR, August 15 — The United States’ Food and Drug Administration (FDA) yesterday approved a new antibiotic to treat highly drug-resistant tuberculosis (TB).

The tablet called pretomanid was developed by nonprofit group, TB Alliance, at a time when few corporations are investing in creating next-generation antibiotics that are often expensive and unprofitable, according to The Washington Post.

“We can have a huge impact on the lives of people who are afflicted and also take a major step ultimately toward, really, the eradication of a disease like TB,” TB Alliance president and chief executive Mel Spigelman was quoted saying.

“One definite advantage of a not-for-profit is you don’t have to look at things like returning your profits into shareholders.”

The Washington Post reported that pharmaceutical companies have mostly stopped producing antibiotics because they can cost up to US$1 billion to bring to market, but return far less revenue than medicines for chronic illnesses like high blood pressure or high cholesterol, or specialty drugs that bring in hundreds of thousands of dollars or more in revenue per dose. Antibiotics are also usually cheap and are taken for only days or weeks at a time, compared to cancer drugs or medicines for chronic illnesses that are taken for months or years.

Pretomanid is only the third new TB drug to be approved by the FDA in more than 40 years; the approval is seen as a successful representation of another potent tool for tackling difficult-to-treat drug-resistant forms of TB.

According to TB Alliance, 95 of its first 107 patients in its clinical trial on a three-drug regimen of pretomanid, taken orally in combination with bedaquiline and linezolid, enjoyed successful outcomes after six months of therapy, significantly exceeding the historical treatment success rate of 34 per cent.

The combination regimen was approved on Wednesday for adult patients with extensively drug-resistant, treatment-intolerant, or non-responsive multidrug-resistant pulmonary TB.

Doctors Without Borders (MSF) welcomed the approval of the new regimen, which the doctors’ group said could dramatically shorten treatment length to six months, but called for pretomanid to be made affordable.

“This newly approved regimen containing pretomanid could be a lifesaver for people with XDR-TB, but it’s not time to celebrate yet.

“The approval of this new regimen by the US FDA is just the first step. We now need pretomanid to be registered and available at an affordable price in all countries, prioritising those with the highest TB burden,” said Sharonann Lynch, HIV & TB Policy Advisor for MSF’s Access Campaign, in a statement.

TB Alliance granted the first license last April to US pharmaceutical corporation Mylan to manufacture, register and supply pretomanid.

But, MSF said, TB Alliance and Mylan have not made any announcement about the price of pretomanid yet. MSF noted that generic versions of pretomanid could be produced and sold at a profit for between US$0.36 and US$1.14 per day.

The lowest global prices for the other two drugs in the regimen, bedaquiline and linezolid, already run at around US$3 per day; people needing this treatment regimen would have to take it for six months, amounting to a total price of US$548, before considering the additional price of pretomanid.

MSF has requested that the treatment for drug-resistant TB to not exceed US$500 per individual for a full course of therapy.

But four months on, the licensing contract has not been made public by either Mylan or TB Alliance, despite calls from civil society for transparency on terms and conditions that will eventually affect people’s access to this drug worldwide, said MSF.

“TB Alliance and Mylan must not squander this opportunity. They must make good on TB Alliance’s mandate to deliver affordable treatment – which is why they received the support of government and philanthropic funding that went into the development of pretomanid and this combination – and provide the drug at an affordable price because when it comes to people with resistant forms of TB, it’s a matter of life or death,” said Lynch.

Pretomanid was developed by TB Alliance and funded by governments in Australia, Germany, the United Kingdom, and the United States, and philanthropic sources, according to MSF.

In addition, TB Alliance stands to be granted a tropical disease priority review voucher (PRV), which it can sell for a substantial amount, said MSF. PRVs have previously been sold for US$67 million to US$350 million. Under the neglected PRV programme, when the FDA approves an eligible neglected disease product—a medicine or vaccine—the developer is awarded a PRV. This voucher can then be used to accelerate the FDA review of any of the developer’s drugs or vaccines. Alternatively, the developer can choose to sell their voucher to another entity, as has been done previously for as much as US$350 million.

MSF called for TB Alliance to use this financial reward to ensure that pretomanid got registered and made available quickly at an affordable price.

On Monday, it has been known that Selangor, Malaysia’s most developed state, recorded 5,071 cases in 2018, making it the state with the highest number of TB cases in Malaysia. The state government is working to come out with plans to stop the increase of TB.

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