J&J's Sirturo gains full US, EU approval after decade-long market presence

Johnson & Johnson (J&J) recently achieved a significant milestone with its tuberculosis medication, Sirturo. After many years of conditional approvals, Sirturo has now received full approval from regulatory authorities in both the United States and Europe. This development follows data from a phase 3 study, which demonstrated that a regimen containing Sirturo led to significantly better treatment outcomes compared to traditional, injectable-containing regimens. The STREAM Stage 2 study was notably the first extensive trial to evaluate an all-oral regimen based on Sirturo.

In 2012, Sirturo initially received accelerated approval from the U.S. Food and Drug Administration (FDA) for treating multidrug-resistant tuberculosis (MDR-TB). Shortly after, in 2014, it secured a conditional approval in Europe. These early approvals were grounded on a surrogate endpoint known as sputum culture conversion, a test that assesses a patient's response to tuberculosis treatment.

Sirturo was groundbreaking as the first tuberculosis medication in over 40 years to offer a new mechanism of action. It has since become integral to global TB treatment practices and is included in the World Health Organization (WHO)'s recommended treatment guidelines. Over the past decade, J&J has collaborated extensively with various communities and governments to ensure the drug's accessibility and sustained efficacy. This includes investments in essential TB systems such as healthcare professional training, resistance testing, surveillance, and supply chain security.

Last year, the humanitarian organization Médecins Sans Frontières (MSF) urged J&J to refrain from enforcing secondary patents on Sirturo in countries heavily burdened by tuberculosis. MSF argued that allowing generic versions could reduce treatment costs by two-thirds, given that Sirturo is the main cost component in the WHO’s recommended six-month treatment regimen. In response to mounting pressure from MSF and other advocacy groups, J&J announced it would not enforce the drug's patents in 134 low- and middle-income countries.

Prior to this, J&J had already granted the Stop TB Partnership's Global Drug Facility (GDF) a license to procure and distribute generic versions of Sirturo to the majority of low- and middle-income countries. This initiative reduced the medication's price by 55% when purchased through the GDF. However, many countries were still excluded from this arrangement, as pointed out by the global health initiative Unitaid in an open letter to J&J’s CEO last year.

The full approvals from both U.S. and European regulators mark a pivotal step for Sirturo, reinforcing its role in the fight against multidrug-resistant tuberculosis. J&J’s ongoing efforts to make Sirturo accessible reflect its commitment to global health and the battle against TB, ensuring that this crucial medication remains available and effective for those in need worldwide.