Biogen's Amevive application on track for early 2003 approval
CAMBRIDGE, MASS., Sept. 12 -- Biogen announced that the FDA has committed to complete the review of its Amevive (alefacept)application within six months.
After review of the information Biogen submitted in reply to FDA's Complete Response Letter, FDA determined it was a class 2 resubmission. Under FDA guidelines, this commits the Agency to completing 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.
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 wellbeing and social
functioning as well as their
Source: Biogen Inc. www.biogen.com
Posted: September 2002