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Published On: Mon, Dec 31st, 2012

Janssen Therapeutic’s ‘Sirturo’ receives FDA approval for treatment of multi-drug resistant pulmonary tuberculosis

TB x-ray

This is an anteroposterior (AP) x-ray of a patient’s chest, who was diagnosed with bilateral pulmonary tuberculosis. Image/CDC

In a follow-up to a Dec. 1 story, Janssen Therapeutics has announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Sirturo (bedaquiline) Tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults, according to a company news release Dec. 31.

The FDA’s accelerated approval program allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. In the case of Sirturo, the accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

The FDA also granted Sirturo fast track designation, priority review and orphan-product designation. The drug demonstrated the potential to fill an unmet medical need, has the potential to provide safe and effective treatment where no satisfactory alternative therapy exists, and is intended to treat a rare disease, respectively.

MDR-TB is considered an orphan disease in the U.S., with 98 reported patients in 2011. MDR-TB is characterized by resistance to two of the most powerful medicines in today’s four-drug standard TB treatment regimen. MDR-TB treatment is complex and requires up to two years of treatment with companion drugs in accordance with national TB treatment guidelines and local MDR-TB treatment practice, along with extensive medical supervision.

Sirturo is the first drug specifically for multidrug-resistant tuberculosis, and the first new type of TB drug in more than four decades.

According to Janssen, the prescribing information for Sirturo includes Boxed Warnings regarding increased risk of death and occurrence of QT prolongation. The Warnings and Precautions section provides additional information regarding these risks and includes risk of hepatic-related adverse drug reactions, drug interactions, use in HIV-TB co-infected patients and treatment failure. The most common adverse drug reactions were nausea, arthralgia and headache. Additional adverse events were hemoptysis and chest pain.

The World Health Organization (WHO) estimates more than two million people will develop MDR-TB between 2011 and 2015.

Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson said, “The accelerated approval of Sirturo is a significant step in the fight against MDR-TB, which is a more difficult to treat form of TB that affects approximately 630,000 people in the world and is on the rise in many areas worldwide.”

“Multi-drug resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don’t have other treatment options.”

Read more about Multidrug-Resistant Tuberculosis (MDR TB)

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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    […] a follow-up to a story earlier this week, the international medical humanitarian organization, Doctors Without Borders/Médecins Sans […]

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