TB drug approvals, distribution deal inches options forward, but MDR TB treatment access still uncertain where needed most

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TBXRAYLast week’s developments in TB treatment included the announcement that bedaquiline, the currently most promising medicine for multi-drug-resistant tuberculosis, will become available to patients in 130 low- and middle-income countries through the Stop TB Partnership’s Global Drug Facility. That good news for multidrug-resistant TB patients, many of whom have run out of other options, was thanks to an agreement signed by drug maker Janssen and GDF procurement agent Strichting International Dispensary Association. It will make the drug, which is marketed as Sirturo, available to national TB programs and to private providers with treatment programs approved by national programs. Bedaquiline, the first new anti-tuberculosis medicine to win U.S. Food and Drug Administration approval in four decades also received approval from the European Medicines Agency the month before.

More good news came on the same day last week — April 30 — with the announcement that the European Medicines Agency had granted approval to delamanid, also to provide a new, needed option for patients with drug-resistant strains of tuberculosis. That medicine, now to be marketed as Deltyba, had advanced further in clinical trials than bedaquiline, before stalling in the approval process after it was submitted to the EMA in late 2011. Turned down for approval by the EMA’s Committee for Medicinal Products for Human Use — known as CHMP —  last July, it languished while drug maker Otsuka filed a successful appeal, which led to CHMP approval in November, which in turn led to last Wednesday’s announcement.

With roughly 450,000 new cases of multi-drug resistant tuberculosis globally in 2012, only half successfully treated, and the potential for 10 to 15 people to become infected by each untreated patient, the need for new treatment approaches with fewer and less damaging side effects has been urgently highlighted in recent years.

For those reasons news last week is promising, Erica Lessem of Treatment Action Group said. Otsuka’s EMA approval will likely ease the way for more, as other countries’ pharmaceutical regulatory authorities look to the stringent FDA and EMA when granting approvals.

“It is an important step forward,” Lessem said. More steps are needed, though, she added, because delaminid/Deltyba remains unapproved in the countries with the heaviest burdens of drug-resistant tuberculosis, including Moldova, which has hosted clinical trials for the drug, while it remains unavailable to most patients. The approval process, which has yet to begin where the drug is needed most, will be lengthy, Lessem cautions. In addition, the price for Deltyba is yet to be established, and that, too will tell how accessible the drug will be.

While welcoming the news that bedaquiline/Sirturo will be available through the Global Drug Facility, Lessem similarly remains concerned that the price of that drug will pose a challenge to countries. At $160 a pill in the United States and other high income countries, a course of treatment runs about $26,000 to $30,000 per patient. In middle-income countries the price is $16 a pill, but with some of those countries being home to both the greatest numbers of both people living in poverty and multidrug-resistant tuberculosis patients that price becomes steep.

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