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Widespread Use Of New TB Drug Faces Challenges, Science Reports

The U.S. Food and Drug Administration (FDA) recently approved the drug bedaquiline, which is used to treat multidrug-resistant tuberculosis (MDR-TB) and is the first TB drug to be approved in more than 40 years, “[b]ut the celebration was tempered because sobering challenges face the drug’s widescale use,” Science reports. Bedaquiline, which was granted licensing…

Reflecting On FDA Approval Of New TB Drug

Noting “[t]he U.S. Food and Drug Administration (FDA) recently announced that it has approved a new treatment for multidrug-resistant [tuberculosis (TB)] that can be used as an alternative when other drugs fail,” Kim Lufkin, communications officer at the Global Health Technologies Coalition (GHTC), writes in the coalition’s “Breakthroughs” blog, “There is a pressing and urgent need for even more new TB drugs, which makes this new FDA approval so significant.” She continues, “It is also noteworthy that the FDA approved Sirturo under its accelerated approval program, in addition to granting the drug fast track, priority review, and orphan-product status,” adding, “It’s critical that the FDA continues to support its priority review, fast track, and similar programs, which can help speed access to safe and effective global health drugs” (1/3).

Wall Street Journal Looks At European Efforts To Fight TB

The Wall Street Journal examines efforts to fight tuberculosis (TB) in Europe, writing, “All along the edges of Western Europe, new and hard-to-defeat strains of tuberculosis are gaining a foothold, often moving beyond traditional victims — alcoholics, drug users, HIV patients — and into the wider population.” The article focuses on the efforts of Estonia to turn the tide against multidrug-resistant TB, saying the country’s success “offers one of the few bright spots globally as the ancient plague mutates into new and more deadly forms.” The newspaper continues, “Indeed, experts say the country, with half the population of Chicago, could be a model for others. But there is one catch: It takes years and some pricey treatments just to gain the upper hand” (Naik, 12/31).

FDA Grants Accelerated Approval To Drug To Treat MDR-TB

“The U.S. Food and Drug Administration [on Monday] approved Johnson & Johnson’s drug to treat a form of resistant tuberculosis that is uncommon in the U.S. but growing globally,” the Wall Street Journal reports. “The drug, Sirturo, will treat patients with multidrug-resistant tuberculosis, or MDR-TB, a possibly fatal disease that affects as many as 630,000 people worldwide who can’t be cured with existing therapies alone,” the newspaper notes (Walker/Tadena, 1/2).

More Work Ahead In TB Drug Development, Treatment Delivery

The U.S. Food and Drug Administration’s approval of the tuberculosis (TB) drug Sirturo, also known as bedaquiline, “appears to be just the first step in an exciting renaissance for TB drug development,” Mark Harrington, executive director of Treatment Action Group (TAG), writes in the Bill & Melinda Gates Foundation’s “Impatient Optimists” blog. “Another new drug, delamanid, is currently in late clinical trials and has been submitted to the European Medicines Agency for review as a treatment for [multidrug-resistant (MDR)] TB,” he notes. Harrington concludes, “It’s an exciting time for TB treatment, but much more needs to be done and more resources are needed. We need to focus not only on the discovery and development of new drugs, but also on ensuring that news drugs are delivered to those who need them and in combinations that can prevent the emergence of new types of drug resistance” (12/28).

U.S. ‘Unprepared For’ Resurgence Of MDR-TB, Wall Street Journal Reports

“Multidrug-resistant [tuberculosis (TB)] is at epidemic proportions in some parts of the world — a growing problem the U.S. is surprisingly unprepared for,” the Wall Street Journal reports. Noting “[t]he U.S. beat back multidrug-resistant tuberculosis [MDR-TB] in the 1990s,” the newspaper continues, “Today, however, a new threat is emerging as drug resistance worsens abroad and far more dangerous strains develop and spread, including some that are all but untreatable with standard drugs.” The Wall Street Journal examines reasons behind a resurgence of MDR-TB in the U.S., treatment and control efforts, and how “funding and expertise are in decline” (12/19).

Continued U.S. Leadership Crucial To Building On Global Progress Against TB

Tuberculosis (TB) “is the second leading cause of death due to infectious disease worldwide; taking approximately 1.4 million lives in 2011 alone,” Rep. Eliot L. Engel (D-N.Y.) writes in an opinion piece in The Hill’s “Congress Blog,” adding, “The good news is that the Millennium Development Goal (MDG) to halt and reverse the TB epidemic by 2015 has already been achieved in several regions of the world.” She notes “advances have been made in TB diagnostics with the increased availability of Xpert, a new test that detects the disease — including in HIV-positive people — within 100 minutes.” However, she continues, “we cannot defeat the disease without the introduction of faster drug susceptibility tests and new drugs and vaccines.”

Global Fund, Nigeria Sign Grants For HIV, TB Initiatives

“On Thursday (Dec. 14), [Nigeria] signed five grant agreements with the Global Fund to Fight AIDS, Tuberculosis and Malaria,” with some of the money going “to provide for antiretroviral therapy treatment and prevention services, particularly on mother-to-child HIV transmission,” Devex’s “The Development Newswire” blog reports. Of the total $335 million, $265 million will go toward HIV/AIDS activities, while $70 million will be used for TB initiatives, the blog notes (Ravelo, 12/14). “For Nigeria, [the] grant agreements address a tremendous need: Nigeria has the second highest number of people living with HIV in the world and only 30 percent of people requiring HIV treatment are receiving antiretroviral therapy,” a Global Fund press release states (12/13).

Stopping TB Requires Dedication Of International Community

Noting that the WHO’s Global Tuberculosis Report shows “that access to care and treatment for tuberculosis [TB] has expanded substantially in the past two decades,” Deborah Derrick, president of Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, writes in an AlertNet opinion piece, “Not only is this good news for those countries that are most vulnerable to tuberculosis; it is also good news for the global community,” as TB can be passed through the air. Derrick describes some of the interventions against TB instituted internationally, and she notes the Global Fund to Fight AIDS, Tuberculosis and Malaria “is the largest global donor to tuberculosis programs, providing 82 percent of international funding to fight the disease,” as well as “91 percent of international financing” to fight multidrug-resistant TB (MDR-TB).

PEPFAR To Buy Additional 150 Rapid TB Testing Devices

PEPFAR will purchase up to 150 rapid tuberculosis (TB) Xpert testing devices and cartridges to test about 450,000 people for TB, “addressing a need to improve diagnoses of drug-resistant strains of disease, and to identify the disease in HIV-positive people in sub-Saharan Africa and Myanmar, the Office of the Global AIDS Coordinator announced” Tuesday, the Center for Global Health Policy’s “Science Speaks” blog reports. “The investment is part of an ongoing effort,” according to the blog, which notes, “The announcement of the program’s added investment in the Cepheid Xpert tests, following the pre-World AIDS Day release last week of PEPFAR’s blueprint for creating an AIDS-free generation backs the plan’s stated purpose of applying evidence-based approaches and scientific advances to confront the global HIV epidemic” (Barton, 12/4).

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