Johnson & Johnson Receives Positive CHMP Opinion Recommending Full Approval for SIRTURO (bedaquiline) for Treatment of Multidrug-Resistant Tuberculosis
Beerse, Belgium, (April 29, 2024) – Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for SIRTURO® (bedaquiline) and the conversion of the medicine’s Conditional Marketing Authorisation into a standard Marketing Authorisation. SIRTURO® is currently indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR TB) in adult and pediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.i The approved indication may vary per country. The Company’s continued support for bedaquiline reflects its longstanding commitment to patients affected by MDR-TB.
The positive CHMP recommendation is supported by data from the Phase 3 STREAM Stage 2 study (NCT02409290), the first large-scale, randomized, multi-country clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for treatment of MDR-TB. Results from the study showed bedaquiline-containing regimens offered a significant improvement over other therapies, confirm the positive risk-benefit of treatment with bedaquiline and were published in The Lancet in November 2022.ii
SIRTURO® was first granted accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2012 and conditional approval by the EMA in March 2014 following positive Phase 2 study data.iii,iv In addition to the Type II variation filed with EMA, a supplemental New Drug Application was submitted to the FDA in August 2023 to support the transition to full approval in the U.S., and is currently under review.v
Johnson & Johnson’s Commitment to TB Patients
Johnson & Johnson has long been committed to helping end tuberculosis. When Johnson & Johnson introduced SIRTURO®, it was the first targeted medicine for TB with a novel mechanism of action to be introduced in over 40 years. Today, it is a core component of World Health Organization-recommended treatment guidelines for drug-resistant TB, and three of every four MDR-TB patients on treatment are receiving a bedaquiline-containing regimen. More than 800,000 courses of the medicine have been shipped to 159 countries.
In 2023, Johnson & Johnson granted the Stop TB Partnership’s Global Drug Facility (GDF) a license that enabled GDF to tender, procure and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries and confirmed its intent to not to enforce patents it owns and controls for SIRTURO® in 134 low- and middle-income countries.vi
In collaboration with partners, Johnson & Johnson has spent the decade since the introduction of the medicine investing in critical TB systems capacity, such as healthcare professional training, resistance testing and surveillance, and supply chain security, to help ensure the medicine is accessible. These efforts include supporting community-centered efforts to help bring more people living with TB into treatment, further expand access to TB medicines and achieve the global goal of ending TB.
About SIRTURO®
EU
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using bedaquiline, please refer to the Summary of Product Characteristics.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding bedaquiline. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
© Janssen-Cilag International NV. All rights reserved.
iEuropean Medicines Agency. SIRTURO Summary of Product Characteristics. May 2023. Available at: SIRTURO, INN- bedaquiline (europa.eu). Accessed: April 2024.
iiGoodall, Ruth L, et al. “Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial.” The Lancet, Volume 400, Issue 10366, 1858 – 1868. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02078-5/fulltext.
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Source:- Johnson & Johnson
