Navigation Links
Concern over fast tracking of new drugs

Concerns over the fast tracking of new drugs for commercial licensing are raised by a senior doctor in this week's BMJ.

It follows approval of natalizumab, a new drug for multiple sclerosis, and its recall three months later, after three trial patients developed a life threatening condition while being treated.

Natalizumab was licensed by the US Food and Drug Administration in 2004 for use in relapsing multiple sclerosis on the basis of short term results from two unpublished trials. The FDA granted approval before final trial and cumulative safety data were available. Natalizumab was predicted to be the leading drug for multiple sclerosis, with estimated annual sales in excess of $2bn.

Around 3000 patients took part in the trials and nearly 5000 patients have been treated in the United States since it became commercially available. In the United Kingdom, natalizumab was due for appraisal by the National Institute for Health and Clinical Excellence in 2006.

But on 28 February 2005, natalizumab was recalled after three trial patients developed progressive multifocal leucoencephalopathy (PML), a rapidly progressive neurodegenerative disease. Two of the patients died.

The approval of natalizumab and its recall after three months raises questions about the fast tracking of new drugs by the FDA for commercial licensing, says the author, consultant neurologist Abhijit Chaudhuri. It also highlights the potential risks for patients in trials of new drugs where knowledge of long term efficacy, outcome measures, and safety is lacking.

Short term solutions for a chronic disease like multiple sclerosis are not likely to be effective, and experience with natalizumab should be taken as a signal to change the way we treat this disease, he concludes.


'"/>

Source:BMJ-British Medical Journal


Page: 1

Related biology news :

1. Findings have implications for tracking disease, drugs at the molecular level
2. Radio-tracking associated with dramatic shift in water vole sex ratio
3. UQ researcher tracking key to healing the brain
4. How satellite tracking revealed the migratory mysteries of endangered Atlantic loggerhead turtles
5. New way of tracking muscle damage from radiation
6. Researchers identify target for cancer drugs
7. MetaChip provides quick, efficient toxicity screening of potential drugs
8. Newly discovered pathway might help in design of cancer drugs
9. UNC launches study of liver injury caused by drugs
10. UCLA study assesses cost-effectiveness of Hepatitis B drugs
11. Sponges as drugs
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/6/2017)... -- Delta ID Inc., a leader in consumer-grade iris scanning ... CES® 2017. Delta ID has collaborated with Gentex Corporation ... of iris scanning as a secure, reliable and convenient ... car, and as a way to elevate the security ... ID and Gentex will demonstrate (booth #7326 LVCC) a ...
(Date:1/4/2017)... LAS VEGAS , Jan. 4, 2017 /PRNewswire/ ... in performance biometric sensor technology, today announced the ... Benchmark™ sensor systems, the highly-accurate biometric sensor ... ® biometric technology, experience and expertise. The ... of Benchmark designed specifically for hearables, and Benchmark ...
(Date:12/22/2016)...  As part of its longstanding mission to improve genetic ... recently released its latest children,s book, titled The ... the topics of inheritance and variation of traits that are ... elementary school classrooms in the US. The ... Ariana Killoran , whose previous book with 23andMe, ...
Breaking Biology News(10 mins):
(Date:1/18/2017)... MA (PRWEB) , ... January 18, 2017 , ... ... today that Dr. Dante Leven successfully implanted SpineFrontier’s A-CIFT™ Solofuse-P™. The operation took ... Center in Valley Stream, NY. The procedure was an anterior cervical discectomy and ...
(Date:1/18/2017)... NY (PRWEB) , ... January 18, 2017 , ... Researchers from a new study ... do not fall low enough after prostate cancer treatment, this indicates there is still remaining ... risk of mortality. , “ The PSA test has always been an indicator of whether ...
(Date:1/18/2017)... (PRWEB) , ... January 18, 2017 , ... Thirty-six startup ... tax credits by the Pennsylvania Department of Community and Economic Development in 2016 as ... are located in the University City Keystone Innovation Zone and represent the highest number ...
(Date:1/18/2017)... 2017 /PRNewswire/ - SQI Diagnostics Inc. (TSX-V: SQD; ... that develops and commercializes proprietary technologies and products ... today announced that Cameron Prange , President ... from its Board of Directors.  Mr. Prange,s resignation ... that have limited both his ability to act ...
Breaking Biology Technology: