Tuberculosis (TB) is one of the world’s greatest health threats.
Today, nearly one-quarter of the world’s population is latently infected with the TB bacteria, and there are more than 10 million new cases of active TB every year. In 2021 alone, there were 1.6 million TB-related deaths.
While most cases of TB can be successfully treated with medication, rising rates of multidrug-resistant tuberculosis (MDR-TB)—that is, cases of TB that don’t respond to the two essential TB drugs recommended for first-line drug-sensitive TB regimens—threaten to put more people at risk. According to the World Health Organization (WHO), there were over half a million new cases of MDR-TB in 2021.
That’s why Johnson & Johnson has had a long-standing commitment to help make TB history.
“Driving innovation in TB has been central to the story of Johnson & Johnson,” says Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D, Johnson & Johnson. “From Paul Janssen’s early research to the development of the first new TB treatment in nearly half a century, we’ve helped progress—and are continuing to advance—the R&D needed to turn the tide of the TB epidemic.”
Over the years, the company has partnered with high-burden countries such as China, India and South Africa to scale up access to its MDR-TB medicine. As a result of these efforts, in 2019 the World Health Organization updated its treatment guidelines to recommend the use of this medicine worldwide, enabling more people in need to benefit from shorter, all-oral treatment regimens. Today, three of every four MDR-TB patients is being treated with an all-oral regimen containing the company’s medicine.
“TB and MDR-TB disproportionately impact underserved communities in low- and middle-income countries,” explains Ana-Maria Ionescu, TB Franchise Leader, Global Public Health, Johnson & Johnson. “Today, we’ve delivered more than 600,000 courses of our medicine and reached patients in 158 countries, including all 30 countries with the highest burdens of MDR-TB, potentially averting more than 5 million new infections.”
Additionally, Johnson & Johnson has sought to address key challenges in the TB epidemic by working to increase TB awareness, train health workers and lead campaigns to encourage more people to seek care. This is critical, because hundreds of thousands of people with MDR-TB go undiagnosed each year, and therefore untreated.
As Johnson & Johnson marks 10 years since the first approval of its medicine to treat MDR-TB this World TB Day, we explore the decades-long role the company has played—from innovations in the lab to reaching patients across the globe—to help bring the world one step closer to achieving its goal of ending the disease.
Today, nearly one-quarter of the world’s population is latently infected with the TB bacteria, and there are more than 10 million new cases of active TB every year. In 2021 alone, there were 1.6 million TB-related deaths.
While most cases of TB can be successfully treated with medication, rising rates of multidrug-resistant tuberculosis (MDR-TB)—that is, cases of TB that don’t respond to the two essential TB drugs recommended for first-line drug-sensitive TB regimens—threaten to put more people at risk. According to the World Health Organization (WHO), there were over half a million new cases of MDR-TB in 2021.
That’s why Johnson & Johnson has had a long-standing commitment to help make TB history.
“Driving innovation in TB has been central to the story of Johnson & Johnson,” says Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D, Johnson & Johnson. “From Paul Janssen’s early research to the development of the first new TB treatment in nearly half a century, we’ve helped progress—and are continuing to advance—the R&D needed to turn the tide of the TB epidemic.”
Over the years, the company has partnered with high-burden countries such as China, India and South Africa to scale up access to its MDR-TB medicine. As a result of these efforts, in 2019 the World Health Organization updated its treatment guidelines to recommend the use of this medicine worldwide, enabling more people in need to benefit from shorter, all-oral treatment regimens. Today, three of every four MDR-TB patients is being treated with an all-oral regimen containing the company’s medicine.
“TB and MDR-TB disproportionately impact underserved communities in low- and middle-income countries,” explains Ana-Maria Ionescu, TB Franchise Leader, Global Public Health, Johnson & Johnson. “Today, we’ve delivered more than 600,000 courses of our medicine and reached patients in 158 countries, including all 30 countries with the highest burdens of MDR-TB, potentially averting more than 5 million new infections.”
Additionally, Johnson & Johnson has sought to address key challenges in the TB epidemic by working to increase TB awareness, train health workers and lead campaigns to encourage more people to seek care. This is critical, because hundreds of thousands of people with MDR-TB go undiagnosed each year, and therefore untreated.
As Johnson & Johnson marks 10 years since the first approval of its medicine to treat MDR-TB this World TB Day, we explore the decades-long role the company has played—from innovations in the lab to reaching patients across the globe—to help bring the world one step closer to achieving its goal of ending the disease.
1926A Man With a Passion for Curing TB
Paul Janssen, the founder of Janssen Pharmaceuticals, now Johnson & Johnson Innovative Medicine, is born in Turnhout, Belgium.
When Janssen was a child, his 4-year-old sister died of tuberculous meningitis. The loss affected him so deeply that it drove him to pursue a career in medicine—and find a new treatment for tuberculosis.
1943The First Anti-TB Drug Debuts
The antibiotic, which was discovered by a researcher in the U.S., is part of a class of drugs called aminoglycoside antibiotics. It is the first effective treatment for TB and works by killing the bacteria that cause the disease.
1965A New Class of Antibiotics Enters the Scene
A novel and potent antibiotic called rifampin is discovered in Italy, which helps cut treatment time from 18 to 24 months to six to nine months, when used in concert with other drugs.
1980sMDR-TB Emerges
In this decade, rates of MDR-TB—which can develop if a treatment is not correctly prescribed or if a patient does not successfully complete treatment—start to soar.
“We’ve seen an increase in drug-resistant tuberculosis for two reasons,” explains Koen Andries, former Janssen Scientist, Belgium. “The first is patients stopping medication too early or not taking all the pills as prescribed, since regimens can be complicated. The second is doctors not prescribing medications correctly.”
2004Janssen Makes a Breakthrough Discovery
Andries and his team find that a compound discovered two years earlier is able to kill off tuberculosis bacteria by blocking a specific enzyme. Janssen researchers use this knowledge to create a new anti-tuberculosis treatment.
One year later, the team publishes a study in the medical journal Science showing that the drug successfully treats MDR-TB in mice.
2009Researchers Have an Aha! Moment
The treatment has a setback, following a disappointing initial Phase 2 clinical trial.
“We tested it for seven days in about 70 patients with pulmonary tuberculosis, but the drug didn’t work,” recalls Anil Koul, Ph.D., Senior Scientific Director and Fellow, Janssen, Belgium.
But researchers like Andries fought to keep it on the table.
“It turns out the drug simply needed more time to become active in the human body—a month, as opposed to a week in mice,” Andries explains.
2012The FDA Grants the Treatment Accelerated Approval
The first medicine for TB in more than 40 years with a novel mechanism of action receives accelerated approval from the U.S. Food & Drug Administration, due in large part to results from a Phase 2 clinical trial.
After 24 weeks of treatment, almost 79% of patients in the group treated with the drug tested negative for TB, compared with only 58% among those not receiving the treatment.
The following year, the World Health Organization releases guidelines recommending the use of the drug, in combination drug therapy, for people with MDR-TB when an adequate regimen cannot otherwise be used because of resistance or intolerance to other drugs.
2014Research Marches On With the Launch of a New Study
Johnson & Johnson announces a collaboration with the International Union Against Tuberculosis and Lung Disease to include the company’s treatment in the STREAM study, a multicenter international trial to evaluate the medicine in patients with MDR-TB.
2015Johnson & Johnson Makes an Unprecedented Donation
The company signs an agreement with USAID and JSC Pharmstandard to donate 30,000 six-month courses of the treatment over the next four years to be used for MDR-TB treatment worldwide. This commitment is later expanded and the company ultimately donates more than 100,000 courses of treatment to 82 countries.
Historia/Shutterstock2016Janssen Wins the International Prix Galien Award
The company garners the prestigious recognition for its TB work. The International Prix Galien Award—named for Galen, the forefather of modern medicine and pharmacology—honors important drugs and research achievements.
“It’s a testament to our company’s perseverance and our commitment to ensuring medical care for some of the world’s most neglected populations,” Draghia-Akli says.
2016A Partnership Brings Aid to Vietnam
Johnson & Johnson and global health nonprofit PATH form a unique partnership in Vietnam called Breath for Life.
The collaboration combines the support of PATH, the National TB Control Program (NTP), the Nghe An Provincial Health Department (PHD) and the Nghe An Provincial Tuberculosis and Lung Disease Hospital (PTLH) to help improve the detection, diagnosis and management of TB in Nghe An, an area in Vietnam with a very high burden of TB.
2017An Innovation-Focused Research Collaboration Is Formed in India
Johnson & Johnson announces a collaboration with India’s Institute of Microbial Technology (IMTech) that’s focused on discovering new treatments for TB.
The hope: pairing IMTech’s world-class expertise in microbial technology with the TB expertise of Janssen scientists will lead to safer, more effective oral treatments and multidrug regimens for MDR-TB.
“Most drug regimens now require taking 10 to 12 pills a day for two years and a daily injection for six months,” Koul explains. “This can be difficult for even the most compliant user, so our ultimate goal is to develop a much safer and shorter treatment regimen and possibly one day even combine several drugs into a single potent pill.”
2018Johnson & Johnson Participates in the First UN High-Level Meeting to Help Accelerate TB Innovations
On September 26, the United Nations holds its first-ever high-level meeting on TB at its headquarters in New York City to help drive progress toward defeating the disease. The theme: “United to end tuberculosis: an urgent global response to a global epidemic.”
Johnson & Johnson attends the meeting, which brings together heads of state to commit to accelerated action to end TB by 2030.
In the lead-up to the event, Johnson & Johnson also hosts the TB Innovation Summit, in conjunction with the Stop TB Partnership, the UN Foundation, the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Economic Forum—and announces a 10-year initiative in support of ending the TB pandemic.
2019The Company Delivers on its Commitment to Ongoing TB Research & Development
The FDA approves a three-drug combination regimen developed by the TB Alliance—which contains Janssen’s medication—for the treatment of extensively drug-resistant TB and treatment nonresponsive or intolerant MDR-TB. This offers a simpler, shorter treatment option for patients who have historically faced lengthy treatment regimens.
2020Johnson & Johnson Expands Access to All-Oral DR-TB Treatment Regimens
In response to the COVID-19 pandemic and new guidelines from the WHO recommending the use of shorter, all-oral drug-resistant TB regimens, Johnson & Johnson initiates a joint effort with the Stop TB Partnership’s Global Drug Facility (GDF), along with support from the Global Fund to Fight AIDS, TB and Malaria and the U.S. Agency for International Development. The effort’s goal is to scale up access to the company’s medicine to adults with MDR-TB through a new access framework.
Thanks to this innovative collaboration praised by the Access to Medicine Index, more than 135 low- and middle-income countries are able to procure and scale up use of the medicine to treat MDR-TB.
“Alongside enabling access, we’re also stewarding our medicine through medication education activities, resistance testing and surveillance and more to ensure future patients can benefit,” says Ionescu. “This includes the provision of dry powder of our MDR-TB medicine, to provide the means to test for whether an individual is infected with strains resistant to the medicine, thus challenging their ability to be treated.”
2020FDA Approval is Granted to a MDR-TB Formulation for Children
In May, the FDA grants approval for a new pediatric version of the company’s medicine to treat MDR-TB as part of combination therapy.
Children are some of the most underserved in the global TB response. With the approval of the pediatric formulation, Johnson & Johnson helps expand access to TB care for children 5 years and older who may have difficulty swallowing an intact tablet. The formulation is later added to the World Health Organization’s List of Essential Medicines for Children.
2022Research on MDR-TB Treatment Continues to Advance
In August 2022, the Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration—a consortium of philanthropic, nonprofit and private sector organizations, of which Johnson & Johnson is a founding member—announces the progression of two investigational TB combination treatments to Phase 2 clinical development, with the company’s MDR-TB medicine as one of the core components of both regimens.
“This will allow us to further explore our medicine’s potential to help transform TB treatment regimens for patients in need while maintaining its long-term effectiveness in the face of rising antimicrobial resistance,” notes Draghia-Akli.
This story was updated in March 2023
Johnson & Johnson’s Quest to End TB
Read about how the company is working to improve detection, broaden access to treatment, and accelerate research and development for the disease over the next decade.
