J&J cuts Sirturo price in South Africa, ending antitrust probe

Johnson & Johnson has recently faced intense scrutiny over the pricing and patenting of its tuberculosis medication, bedaquiline, known commercially as Sirturo. The situation reached a peak last year, but now appears to be resolving.

The South African Competition Commission has decided to drop its investigation into Johnson & Johnson and its subsidiary, Janssen. This investigation was initiated last summer after the companies applied for a secondary patent to extend market exclusivity and delay generic competition until 2027. According to a press release, the commission decided to halt the complaint following extensive discussions with Johnson & Johnson.

A significant factor in this decision was Johnson & Johnson's commitment to not enforce its Sirturo patent in 134 low- and middle-income countries, including South Africa. Additionally, the company agreed to reduce the procurement price for the South African government by 40%. This new pricing aligns with what Johnson & Johnson charges the Stop TB Partnership’s Global Drug Facility (GDF), which supplies medications to the majority of low- and middle-income countries.

In 2022, Johnson & Johnson had already reduced the price of Sirturo for the GDF by 55%, a move hailed as a historic price reduction. However, this arrangement initially excluded several countries facing significant challenges with multidrug-resistant tuberculosis, such as South Africa, Belarus, and Ukraine. Following this, Johnson & Johnson expanded its agreement, pledging not to enforce Sirturo patents in certain low- and middle-income countries. This expansion allows generic manufacturers to produce and sell their versions of the drug, provided they meet quality and medical standards and are distributed only in the specified countries.

This decision came after significant pressure from various advocacy groups, including Unitaid and Médecins Sans Frontières, who have been vocal about the need for increased access to essential medications like Sirturo.

Sirturo received accelerated approval from the U.S. FDA in 2012, marking it as the first new tuberculosis drug with a novel action mechanism in over four decades. Since its approval, Sirturo has become an essential component of global tuberculosis treatment protocols and is included in the World Health Organization’s recommended treatment guidelines.

Most recently, regulators in the United States and Europe have granted full approvals for Sirturo, upgrading the previous conditional approvals. This marks a significant milestone in the drug's regulatory journey, solidifying its status as a critical treatment for tuberculosis worldwide.

The South African Competition Commission's decision to close the investigation, combined with Johnson & Johnson's commitments and price reductions, marks a significant step forward in making vital tuberculosis treatment more accessible to those in need, particularly in low- and middle-income countries. This development is a positive outcome for global health, ensuring wider access to a crucial medication and potentially saving countless lives.