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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation
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To: scaram(o)uche who started this subject9/12/2002 8:28:10 PM
From: scaram(o)uche  Read Replies (1) of 631
 
[ Biogen/LFA3tip (Amevive) status ]

Biogen's AMEVIVE(R) (Alefacept) Application on Track for Early 2003 Approval
Thursday September 12, 6:00 pm ET

CAMBRIDGE, Mass., Sept. 12 /PRNewswire-FirstCall/ -- Biogen, Inc. (Nasdaq: BGEN - News) today announced that the Food and Drug Administration (FDA) has committed to complete the review of its AMEVIVE® (alefacept) application within six months. After review of the information Biogen submitted to reply to FDA's Complete Response Letter, FDA determined it was a class 2 resubmission. Under FDA guidelines, this commits the Agency to complete the review within six months. Biogen is now one step closer toward the approval of AMEVIVE for the treatment of moderate-to-severe chronic plaque psoriasis.
(Photo: newscom.com )
Psoriasis is a T-cell mediated inflammatory disorder of the skin that can cause considerable discomfort. It is a disease for which there is no cure, affecting people of all ages. According to the American Academy of Dermatology, psoriasis affects 3-5 million people in the United States and about another 100 million people worldwide. Although individuals with mild psoriasis can often control their disease with topical agents, more than one million patients worldwide require ultraviolet or systemic immunosuppressive therapy. According to the National Psoriasis Foundation, the disease impacts a person's psychological well being and social functioning as well as their physical functioning.

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