FDA, Insmed, Inc. Announce Special Program for IPLEX and

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FDA, Insmed, Inc. Announce Special Program for IPLEX and Powered By Docstoc
					                                  FDA, Insmed, Inc. Announce
                               Special Program for IPLEX and ALS

The U.S. Food & Drug Administration has granted approval for a limited number of people with ALS in the
United States to receive IPLEX, a drug that combines insulin-like growth factor (IGF-1) and IGF binding
protein 3. IPLEX, which has not been approved for use in ALS, is manufactured by Richmond, VA-based
Insmed, Inc. The new program is the result of an agreement between the FDA and Insmed.

The ALS Association hopes that the FDA-approved program will develop informative data about IPLEX
that can lead to a better understanding of its efficacy and safety and enable both patients and clinicians to
make more informed decisions about the use of IPLEX and its potential as a therapy for ALS. To this
end, The Association encourages the FDA and Insmed to establish partnerships with the ALS community
to ensure that the program yields meaningful results that will guide the next steps in determining whether
IPLEX is effective and safe for ALS.

IPLEX originally was approved in the United States as a treatment for children with growth failure, but it is
now discontinued and no longer available for this population. The drug is being tested in a now-closed
study involving myotonic muscular dystrophy (MMD). Insmed is supplying IPLEX to the Italian
government under an "expanded access program," but it continues to be an untested and unproven
treatment for ALS in the United States.

Based on existing clinical and scientific evidence, The ALS Association cannot encourage or recommend
the off-label use of this medication without substantive evidence of its efficacy through a rigorous clinical
trial. The ALS Association is continuing to monitor and assess information about IPLEX as it becomes
available to provide the public with the most up-to-date reports about its potential for ALS.

Additional information on today's announcement is available here: http://www.fda.gov.

For more information please contact iplex_als@insmed.com or 804-565-3083.

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