Genmab's HuMax-CD4 wins fast track status

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Genmab's HuMax-CD4 wins fast track status

Feb 21, 2002 (Datamonitor) - Genmab and Neuer Markt's HuMax-CD4 has been

designated a fast track product by the FDA. HuMax-CD4 is in Phase III

studies to treat patients with active rheumatoid arthritis who have

failed to respond to treatment with Methotrexate and TNFalpha blocking

agents.

Under the FDA Modernization Act of 1997, designation as a fast track

product means that the FDA will facilitate the development and expedite

the review of a drug if it is intended for the treatment of a serious or

life-threatening condition, and it demonstrates the potential to address

unmet medical needs for such a condition. This fast track designation

gives Genmab the opportunity to submit a Biologics License Application

(BLA) in sequential sections, and have these sections reviewed as they

are submitted, thus saving development time. A BLA is the biologic

products equivalent to a New Drug Application and is the final stage

before a drug is approved for the market by the FDA. Fast track status

also opens the possibility for receiving a priority review of the BLA

where the review time would be halved to just six months. " Fast Track

status accelerates the development time table for HuMax-CD4, " said Dr

N Drakeman, Genmab's CEO, in a company statement. " There are

hundreds of thousands of patients who could benefit from additional

treatment options. "