FDA Grants Accelerated Approval to Janssen’s Tuberculosis Drug

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The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on Aug. 9, 2019, that FDA granted accelerated approval for Sirturo (bedaquiline) tablets as part of combination therapy in pediatric patients with pulmonary multidrug-resistant tuberculosis (MDR-TB). The drug is indicated for pediatric patients in the United States who are over the age of 12, younger than 18, and weigh at least 66 pounds and is meant to be used when an effective treatment regimen cannot otherwise be provided. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials. 

The company is also planning additional global regulatory filings and has further research ongoing in children younger than 12 years of age using a pediatric formulation of the API.

In 2017, an estimated one million children became ill with TB, and 230,000 children died of the disease, according to the company. Approximately 95% of childhood deaths from TB occur in Asia and sub-Saharan Africa.

“We are proud of what today’s approval means for adolescent patients in the US, and we are hopeful about the future of our pediatric R&D program,” said Paul Stoffels, MD, vice chair of the executive committee and chief scientific officer, Johnson & Johnson, in a company press release. “Despite being a major global health issue, TB lacks the attention and resources it requires-and the issue of TB in children is even more neglected. At Johnson & Johnson, we are committed to developing solutions that address the needs of all TB patients, including the youngest and most vulnerable.”


"In the past, MDR-TB was a diagnosis that left patients with few options. But fortunately, new treatments and other tools have brought a renewed sense of hope for patients,” said Jaak Peeters, global head, Johnson & Johnson Global Public Health, Janssen-Cilag GmBH, in the press release.

Source: Johnson & Johnson