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www.natap.org
PegLambda Discontinued by BMS
I am writing to let you know about a recent decision Bristol-Myers Squibb has made regarding the development of our investigational product, Peginterferon Lambda, for the treatment of chronic hepatitis C (HCV).
After thoroughly reviewing the latest available clinical data for Lambda and following careful consideration of the rapidly developing field of HCV treatment, we have decided to discontinue the Lambda HCV development program and will no longer be seeking regulatory review of Lambda, globally. We have concluded that given the very promising developments in HCV in terms of emerging all-oral therapeutic options, Lambda would no longer fulfill the unmet need that we had envisioned upon initiation of the clinical trials. Patients currently enrolled in on-going clinical trials will have the option to complete their assigned treatment regimen and continue the Lambda trials through an appropriate endpoint, which is generally SVR12.
We wanted to share this with you in order to answer any questions you may have as a leading advocate. All involved investigators have been informed and the information is currently being shared with patients. We invite you to share the below communication with your members, as you consider appropriate.
We would like to take this opportunity to reinforce that our late-stage HCV DAA development program remains unaffected.
We are happy to discuss further and invite any questions/feedback you may have.
Sincerely,
David Richwine
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发表于 2014-8-20 13:57
