Petersen , E and Hui, DS and Nachega, JB and Ntoumi, F and Goletti , D and Aklillu , E and Sharma, A and Varghese, GM and Zumla, A (2023) End of the Bedaquiline patent – a crucial development for moving forward affordable drugs, diagnostics, and vaccines for infectious diseases in low- and middle-income countries. International Journal of Infectious Diseases, S1201- (23). 00517-00519.

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Abstract

When Johnson & Johnson (J&J) developed the new tuberculosis (TB) drug bedaquiline (Sirturo),[1] it was one the few new drugs to have been conditionally approved by the United States Food and Drug Administration (FDA) in 2012 for treatment of multi-drug resistant tuberculosis (MDR-TB). It offered renewed hope to patients providing a unique opportunity to radically transform management of MDR-TB to shorter, easier-to-administer, and more patient-tolerable treatment regimens.[2] Evaluation in clinical trials over the ensuing seven years showed that bedaquiline was a game-changer, demonstrating substantial improved treatment outcomes among people with MDR-TB and extensively drug-resistant TB (XDR-TB).[3] J&J, like all pharmaceutical companies who hold the patent rights on drugs, had the sole authority over setting the high price of bedaquiline. In October 2019 Médecins Sans Frontières (MSF), TB activists and civil society launched a global campaign protesting outside J&J offices in the United States, South Africa, Brazil, Belgium, Ukraine and Spain calling on lowering the price of bedaquiline to no more than US$ 1 per day for patients with MDR-TB, so as to allow rapid scale-up and the ability to treat patients, rendering them non-infectious and reducing further spread within the community.[3] Bedaquiline is now considered an essential drug in an all-oral treatment regimen for MDR-TB.[2,4,5] The rates of MDR-TB have, however, remained extremely high in Asia, Africa and Eastern Europe and deaths due to drug-resistance remain high. [5] Most of the estimated annual 500,000 MDR-TB cases do not have access to oral MDR-TB treatment regimens due to their high cost, lack of affordability, and limited availability.

Item Type:	Article
Additional Information:	National Centre for Cell Science, Pune, India.
Subjects:	Insect Molecular Biology
Depositing User:	Mr. Rameshwar Nema
Date Deposited:	18 Apr 2023 11:36
Last Modified:	18 Apr 2023 11:36
URI:	http://nccs.sciencecentral.in/id/eprint/1256

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