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and Drug Administration in 2004 for use in relapsing multiple sclerosis on the basis of short term results from two unpublished trials.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:3/28/2017)... , March 28, 2017 The ... Hardware (Camera, Monitors, Servers, Storage Devices), Software (Video Analytics, ... Region - Global Forecast to 2022", published by MarketsandMarkets, ... 2016 and is projected to reach USD 75.64 Billion ... and 2022. The base year considered for the study ...
(Date:3/24/2017)... 24, 2017 The Controller General of Immigration from ... Abdulla Algeen have received the prestigious international IAIR Award for the ... Continue Reading ... ... Controller Abdulla Algeen (small picture on the right) have received the IAIR ...
(Date:3/23/2017)... The report "Gesture Recognition and Touchless Sensing Market by Technology (Touch-based ... to 2022", published by MarketsandMarkets, the market is expected to be worth USD ... 2022. Continue Reading ... ... ...
Breaking Biology News(10 mins):
(Date:10/11/2017)... and LAGUNA HILLS, Calif. , Oct. ... Cancer Research, London (ICR) and University ... SKY92, SkylineDx,s prognostic tool to risk-stratify patients with multiple myeloma ... MUK nine . The University of Leeds ... partly funded by Myeloma UK, and ICR will perform the ...
(Date:10/10/2017)... ... 2017 , ... San Diego-based team building and cooking events company, Lajollacooks4u, has ... The bold new look is part of a transformation to increase awareness, appeal to ... period. , It will also expand its service offering from its signature gourmet cooking ...
(Date:10/10/2017)... 10, 2017 International research firm Parks Associates announced ... at the TMA 2017 Annual Meeting , October 11 in ... residential home security market and how smart safety and security products impact ... Parks Associates: Smart Home ... "The residential security market has ...
(Date:10/9/2017)... DIEGO , Oct. 9, 2017  BioTech ... biological mechanism by which its ProCell stem cell ... critical limb ischemia.  The Company, demonstrated that treatment ... amount of limbs saved as compared to standard ... the molecule HGF resulted in reduction of therapeutic ...
Breaking Biology Technology: