Navigation Links
MS Drug Fails The Test For Treating Crohns Disease

Biogen Idec's chief executive, James Mullen is not a happy man. The Cambridge biotechnology company is not likely to receive approval from European regulators to use its drug Tysabri to treat patients with Crohn's disease, a debilitating intestinal ailment.

Results from drug trials that were included in an application to the European Medicines Agency were marked as "interesting but need more development". Now, an additional clinical trial proposed by the agency could take years and cost Biogen Idec millions of dollars, says Mullen.

Biogen Idec and Elan Corp. of Ireland have partnered on development of Tysabri since 2001. After showing promising results in testing, the drug was introduced in the United States in November 2004 to treat patients with multiple sclerosis, but was abruptly withdrawn from the market after the companies found two patients in Tysabri trials had contracted a potentially fatal brain disease. Ultimately, three patients were found to have contracted the brain disease, progressive multifocal leukoencephalopathy, or PML, and two died from it.

Yet, after impassioned testimonies from multiple sclerosis patients anxious for a chance to try Tysabri, the Food and Drug Administration permitted sales to resume, but Biogen Idec was required to take additional safety precautions, including a mandatory registry of patients receiving the drug.

In recent public statements, officials from Biogen Idec and Elan touted Tysabri's ability to induce remission in Crohn's patients. In their partnership, Biogen Idec has led trials and regulatory filings related to multiple sclerosis, and Elan has overseen the potential expansion of Tysabri as a treatment for Crohn's disease. "The data suggest that Tysabri could be an alternative biologic choice for Crohn's disease patients, says Elan.As the data continue to unfold, [Elan and Biogen Idec] will explore additional indications, as appropriate, to unmet medical needs", the company was quoted.

In a comprehensive safety review last year, the companies found two multiple sclerosis patients with PML who were also being treated with Biogen Idec's drug Avonex, another treatment for multiple sclerosis. One of those patients survived. Another patient in a Crohn's trial, who died from PML, had been treated with immunosuppressants.

This pattern, according to experts, suggests that the risks of contracting PML while using Tysabri could increase if a patient is also being given a drug that affects the immune system. If so, that raises the risks of treating Crohn's patients with Tysabri, because many have weakened immune systems.

"Against the backdrop of PML, where you have a set of patients that already get bombarded with immunosuppressants over 20 to 30 years, [Crohn's] is not the first place we'd go to develop Tysabri," states Mullen. According to him, the drug looks more promising as a treatment for Lupus and certain cancers.


'"/>




Related medicine news :

1. Alcoholism Drug Fails To Prevent Drinking Relapses
2. Tamiflu Fails To Save Two Lives
3. Himachal Pradesh Fails To Become Health Tourism Center
4. Budhias Medical Report Fails to Address Long Term Health Issues
5. "Daydreaming" Network Fails In Autism
6. 72-year-old Bachelor of Rajasthan Fails Class 10 Again!
7. Already Short Staffed And In Deficit NHS Fails To Supply Staff For IT Project
8. NHS 24 Fails To Save a Retired Nurse
9. Smartcard Legislation Fails The Privacy Test - AMA
10. Support Fails Rural Heart Patients
11. Steroid Use Fails to Boost Pregnancy Rates in Infertility Treatments
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:12/8/2016)... ... December 08, 2016 , ... The West Virginia ... 1, 2017. The name change aligns the entire company with its existing ... care quality. , “We are very proud of the achievements associated with the ...
(Date:12/8/2016)... ... December 08, 2016 , ... After enjoying record-breaking attendance at ... for its 33rd Annual Issues & Research Conference, March 2-3, 2017, at ... the conference is “Persistent Challenges and New Opportunities: Using Research to Accelerate the ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... “Natural Language Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health ... . , Results of the comparative usability study demonstrate that a dictation-based method ...
(Date:12/8/2016)... ... December 08, 2016 , ... Mirixa Corporation , a ... other pharmacist-delivered patient care services, has announced the promotions of Karen Litsinger to ... president of sales. , Litsinger joined Mirixa in 2008 after serving as ...
(Date:12/8/2016)... ... ... With the increasing demand for dental implants, the National Association of Dental ... dentists and patients about the safety issues related to dental restorations. According to the ... is projected to reach $6.4 billion in 2018 with more than 30 million Americans ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... QUEBEC CITY , Dec. 8, 2016 /PRNewswire/ ... key US patents for improving the accuracy, reproducibility ... CD images in long and small bone orthopaedic ... proprietary approach to creating personalized orthopaedic restorations based ... create personalized orthopaedic restorations, the company harnesses the ...
(Date:12/8/2016)...  A new study by a pair of Geisinger ... therapy to treat chronic pain is not only ineffective, ... consequences, including death. Palliative care physicians ... , M.D., authored the study which provides a review ... study was published in the December 2016 edition of ...
(Date:12/8/2016)... Information products and services provider Elsevier has launched ... world,s largest abstract and citation database of peer-reviewed literature, providing the ... 5,000 publishers. The new set of metrics will improve decisions on ... adjust a journal,s editorial strategy. ... , CiteScore metrics comprise ...
Breaking Medicine Technology: