A storm of scrutiny relating to Johnson & Johnson’s pricing and patenting of its tuberculosis med bedaquiline (branded as Sirturo) is clearing up after reaching a fever pitch last year.
South African antitrust authorities have dropped (PDF) an investigation they opened into J&J last summer after the drugmaker and its Janssen subsidiary filed for a secondary patent that sought to fend off generics until 2027.
The country’s Competition Commission decided not to move forward with a complaint after “extensive engagements” with the Sirturo maker, the commission said in a press release. Along with J&J's prior commitment to not enforce its Sirturo patent in 134 low-and middle-income countries (including South Africa), the company agreed to slash the South African government's procurement price by 40%.
The new price matches the figure that J&J offers to the Stop TB Partnership’s Global Drug Facility (GDF), according to the commission. GDF supplies the med to “the majority of low-and middle-income countries,” J&J has said.
Last year, J&J cut its Sirturo prices for GDF by 55% in what the organization called a “historic price reduction.”
However, the GDF deal left out several countries with a high burden of multidrug-resistant tuberculosis, including South Africa, Belarus and Ukraine, global health initiative Unitaid said at the time.
Soon after disclosing its GDF partnership, J&J widened its pact and pledged to not enforce Sirturo patents in certain low-and middle-income countries, allowing generics makers to sell their own versions of the med if they are “of good quality, medically acceptable” and used only in the appropriate countries.
The move came after several advocacy groups, such as Unitaid and Médecins Sans Frontières, pressed the company to expand access to the drug.
Sirturo scored an accelerated approval from the FDA in 2012, becoming the first tuberculosis med to offer a novel mechanism of action in more than 40 years. Since then, the drug has become a staple of worldwide tuberculosis treatment and is listed in the World Health Organization’s recommended treatment guidelines.
Earlier this week, regulators in the U.S. and Europe granted Sirturo full approvals, converting their prior conditional approvals.