Tuesday, July 22, 2014
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FDA approves Sirturo for multi-drug resistant tuberculosis

The FDA's approval of Sirturo to treat multi-drug resistant tuberculosis, despite safety concerns, was certainly a high note for Janssen, the Johnson & Johnson subsidiary which makes the drug.

FDA approves Sirturo for multi-drug resistant tuberculosis

The FDA's announcement of approval of Sirturo to treat multi-drug resistant tuberculosis was certainly a high note for Janssen, the Johnson & Johnson subsidiary which makes the drug in Titusville, N.J.

"Sirturo was first discovered in our laboratories more than a decade ago and it is gratifying to see our discovery and development lead to the accelerated approval of the first TB therapy in 40 years with a new mechanism of action. This underscores our commitment as a company to discover, develop and responsibly deliver innovative medicines that address serious unmet medical needs," Dr. Paul Stoffels, chief scientific officer of pharmaceuticals at Johnson & Johnson, said in a statement.

Tuesday's Inquirer story is here.

Some prominent organizations cheered, albeit with caution. Another not so much.

Before the announcement, Public Citizen had urged the FDA not approve the drug. It was a bit concerned that the drug had not yet completed all of the phase two trials and that in one trial, more people died while taking Sirturo than the placebo.

The link to the Public Citizen page, with press release and link to its letter to the FDA, is here.

Doctors Without Borders/Médecins Sans Frontières (MSF), which is not shy about criticizing when it decides pharmaceutical companies are focusing too much on profits, said the news was good, but urged J&J to make the drug available at a reasonable price.

When the Inquirer asked about the planned price, a J&J spokeswoman declined comment, saying it was not yet to the commercialization stage.

“The first new drug to treat TB in 50 years is an immense milestone,” Dr. Manica Balasegaram, executive director of the MSF Access Campaign, said in a statement. “The fact that the drug is active against drug-resistant forms of the disease makes it a potential game changer.”

MSF noted that a second new drug to treat MDR-TB called delamanid is being developed by the Japanese company Otsuka, is being looked at by the European Medicines Agency and could be approved for use in 2013.

On the price issue, MSF said, "The companies should make the drugs available for research in order to develop shorter, more effective regimens, to register them in high-burden countries as quickly as possible once they have been approved, and to ensure they are affordable in countries where they are needed most."

The full MSF statement is here.

The Gates Foundation has given lots of money to fight diseases all over the world, including TB.

Dr. Lee Reichman, the executive director of New Jersey Medical School Global Tuberculosis Institute at UMDMJ, is among those who got Gates Foundation money to study TB. He is also paid by J&J.

"This is the first time a new drug is being introduced specifically for MDR-TB, for which the current needs are so great," Reichman said in the J&J statement. "It is an important step in the development of new compounds for this serious and contagious disease."

A link to the FDA announcement is here, and that statement has links to a Q&A and info from the U.S. Centers for Disease Control and Prevention.

A link to the complete J&J-Sirtura label and medication guide is here.

A link to the World Health Organization's web page with 10 facts about tuberculosis is here.

 

 

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

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