Complete Response Letters
Amgen Inc.: Kanjinti
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 25, 2018
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Jul 13, 2017
Preliminary findings from Study 20110142 show a higher incidence of cardiovascular serious adverse events with romosozumab compared to alendronate in women with postmenopausal osteoporosis.
CRL_BLA761062_20170713:p1:s18A similar signal was seen in Study 20110174, a smaller study comparing romosozumab to placebo in men with osteoporosis.
CRL_BLA761062_20170713:p1:s19This should include the basis for your conclusion that the benefits of romosozumab outweigh the identified cardiovascular risks.
CRL_BLA761062_20170713:p1:s25We recommend that you request a meeting to discuss the details of your proposal for responding to the deficiency before you resubmit the application.
CRL_BLA761062_20170713:p1:s27Complete Response Letter, Aug 27, 2015
BLA 125522 provides for the use of Repatha (evolocumab) for the following indications which, for administrative purposes, we have designated as follows:
CRL_BLA125522_20150827:p1:s22The subject of this action letter is BLA 125522/Original 2. A separate action letter will be issued for BLA 125522/Original 1.
CRL_BLA125522_20150827:p1:s27All future submissions to BLA 125522/Original 1 and BLA 125522/Original 2 should specify the BLA number and the Original number to which each submission pertains.
CRL_BLA125522_20150827:p1:s30More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.