|
|
|
|
|
|
|
Free Newsletters
Archive
My Subscriptions
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers
Regional News
US & Canada
Biotech Bay
Biotech Beach
Genetown
Pharm Country
BioCapital
BioMidwest
Bio NC
BioForest
Southern Pharm
BioCanada East
US Device
Europe
Asia
Market Summary
News
IPOs
Company Profiles
Companies
Events
Research Store
Biotech Events
Post an Event
Real Estate
Business Opportunities
|
|
|
|
|
News | News By Subject | News by Disease |
News By Date | Search News
|
|
|
Will FDA Grant Accelerated Approval to Johnson & Johnson (JNJ) TB Drug?
12/28/2012 6:56:25 AM
As a deadline looms today for the FDA to grant accelerated approval to a new, first-in-class medication for treating tuberculosis, a watchdog group is urging the agency not do so, because clinical trials demonstrated an “alarming increased risk of death.” The drug, which is called Sirturo, or bedaquiline, was developed by Johnson & Johnson. In a recent letter to the FDA, Public Citizen says the FDA should not confer accelerated approval – which is granted to meds to treat serious diseases and fill an unmet medical need based on a surrogate endpoint – because patents taking the drug in addition to standard TB treatment during a Phase II trial were five times likelier to die than those who took a placebo. “It is not possible to conclude that a surrogate endpoint is “reasonably likely” to predict benefit for patients — as required by FDA regulations — when the same clinical trial of a drug using that surrogate endpoint shows a significant increase in mortality, regardless of the drug’s effects on the surrogate marker,” the watchdog writes to the FDA. “The only reasonable conclusion in such cases is that the selected surrogate endpoint is, in fact, not a valid or useful marker of clinical benefit; its surrogate ‘benefit’ is trumped by increases in the adverse clinical outcome — death — nullifying the use of the favorable surrogate marker as a means of granting accelerated approval.” Public Citizen, in fact, goes on to say that the NDA, or New Drug Application, for bedaquiline should never have been brought before an FDA advisory committee for consideration. Late last month, however, the Anti-Infective Drugs Advisory Committee voted unanimously to recommend that the FDA grant accelerated approval status.
|
|
|
|
|
|
|
|
|
|
|