It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods.
Regulators on both sides of the Atlantic granted the full approvals based on data from a phase 3 study showing that a Sirturo-containing regimen delivered a “significant improvement” in treatment outcomes compared to other, injectable-containing regimens, according to a recent company press release. The STREAM Stage 2 study was the first large-scale trial to evaluate an all-oral Sirturo-based regimen.
J&J filed its bids for the full approvals last year. In Europe, the decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Sirturo first hit the scene in the U.S. in 2012 with an FDA accelerated approval for the treatment of multidrug-resistant tuberculosis (MDR-TB), which was followed by a 2014 conditional nod in Europe. Those approvals were based on a surrogate endpoint of time to sputum culture conversion, a test that measures a patient’s response to tuberculosis treatment.
Upon its prior accelerated and conditional approvals, Sirturo became the first tuberculosis med to offer a novel mechanism of action in more than 40 years. The drug is now a staple of worldwide TB treatment and holds a position in the World Health Organization (WHO)’s recommended treatment guidelines.
In the decade since the first approvals, J&J has been busy working with communities and governments to “help ensure the medicine is accessible and remains effective for patients today and tomorrow,” the company said in its recent release.
The drugmaker’s efforts include investing in “critical TB systems capacity” such as healthcare professional training, resistance testing and surveillance and supply chain security.
Last year, Médecins Sans Frontières (MSF) called on the company to commit to not enforcing secondary patents on Sirturo in countries with a high tuberculosis burden. As the main cost driver in the WHO’s recommended six-month treatment regimen, allowing generics could slash treatment costs by two-thirds, MSF said at the time.
J&J eventually responded to the swirling pressure from MSF and other advocacy groups with an announcement declaring its intent to not enforce the drug's patents in 134 low- and middle-income countries.
Before that, the company had granted the Stop TB Partnership's Global Drug Facility (GDF) a license allowing the GDF to procure and supply generic Sirturo versions to “the majority of” low-and middle-income countries. That approach did cut the med’s price by 55% when purchased through GDF but left many countries out, global health initiative Unitaid said in an open letter to J&J’s CEO last year.