THOUSAND OAKS, Calif., April 28, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it agreed last night with the FDA's proposed post-marketing requirement to conduct, as part of the ongoing development program, a multi-center randomized clinical trial to compare the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower daily dose of the drug. Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose.
Amgen anticipates the results from the study in late 2022 and does not expect any impact on the timelines of the ongoing priority review of LUMAKRAS™.
Amgen Forward-Looking Statements
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
CONTACT: Amgen, Thousand Oaks
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
Telephone 805-447-1000
www.Amgen.com
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060 (investors)
1The trade name LUMAKRAS™ is provisionally approved for use by the U.S. FDA
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