The Quest to End Tuberculosis: 17 Memorable Moments in Innovation

Paul Janssen, the founder of Janssen Pharmaceuticals, part of the Johnson & Johnson family of companies, 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.

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.

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.

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, Koen Andries,former Janssen Scientist, Belgium 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.”

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.

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. Anil Koul, Ph.D.,Senior Scientific Director and Fellow, Janssen, Belgium, 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.

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.

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.

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.

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.

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.

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.”

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.

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.

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."

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.

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