NEWS - UCB's metting with US FDA defines path forward for Cimzia in RA

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MedicalNewsToday.com

Article Date: 06 Feb 2009 - 2:00 PST

UCB's Meeting With U.S. FDA Defines Path Forward For Cimzia® In

Rheumatoid Arthritis.

UCB announced that it met the U.S. Food and Drug Administration (FDA)

and clarified the requirements for the approval of the Biologics

License Application (BLA) for Cimzia®, the first PEGylated anti-TNF,

for the treatment of rheumatoid arthritis (RA).

During the meeting, the FDA communicated that they require further

analysis of existing data and a new safety update. No additional

studies (clinical or non-clinical) are needed to fulfill this request.

" UCB is working diligently with the FDA to fulfil its request and, due

to the already rich database available for Cimzia® in rheumatoid

arthritis, we anticipate submitting the full response for Cimzia® in

the second quarter of this year, " said Prof. Dr. Iris Loew-Friedrich,

Chief Medical Officer of UCB.

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