Jump to content
RemedySpot.com
Sign in to follow this  
Guest guest

Anti-CD23 Drug for CLL Gets Fast Track Nod from FDA

Rate this topic

Recommended Posts

Guest guest

Biogen gets fast track, orphan status for leukemia drug

Triangle Business Journal - 11:56 AM EST Wednesday, February 7, 2007

Biogen Idec said Wednesday that its leukemia drug lumiliximab (anti-

CD23)has been granted fast track and orphan drug designations by the

U.S. Food and Drug Administration.

Fast track status ensures an accelerated regulatory review process

for experimental drugs that treats serious diseases such as cancer.

Orphan drug designation provides tax breaks and an extended period

of market exclusivity for drugs with limited sales potential that

otherwise would be too expensive to make.

Cambridge, Mass.-based Biogen (Nasdaq: BIIB) said Wednesday it has

launched a human trial on lumiliximab on patients with chronic

lymphocytic leukemia. The trial will compare treatment with

lumiliximab in combination with fludaribine, cyclophosphamide and

rituximab (FCR) to FCR alone in patients with CLL that have relapsed

or failed to respond to initial therapy. The trial enrolled its

first U.S. patient in January, the company said in a statement.

" We are pleased that the FDA has recognized the unmet medical need

of patients with chronic lymphocytic leukemia, and we believe that

this fast track designation may be an important step towards

bringing lumiliximab more rapidly to the market, " said Dr.

Parkinson, senior vice president of oncology research and

development at Biogen Idec.

Chronic lymphocytic leukemia is a cancer that starts in lymphocytes,

or white blood cells, of the bone marrow. It then invades the blood

and can spread to the lymph nodes, spleen, liver and other parts of

the body. It is estimated that 77,000 Americans are currently living

with CLL, and about 10,000 new cases are expected to occur in the

United States this year.

Share this post


Link to post
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
Sign in to follow this  

×
×
  • Create New...