That big new hy­per­parathy­roidism drug from Am­gen? The FDA re­ject­ed it

Ac­cord­ing to reg­u­lar up­dates from Am­gen over the past two years, in­ves­ti­ga­tors marched through a trio of late-stage stud­ies for etel­cal­ce­tide (AMG416) with noth­ing but good things to re­port. The drug scored out­stand­ing da­ta for sec­ondary hy­per­parathy­roidism (SH­PT), a dis­ease that af­fects chron­ic kid­ney dis­ease pa­tients on he­modi­a­lyis.

And this evening Am­gen re­port­ed that the drug was re­ject­ed by the FDA. The news came in a terse state­ment, with­out a hint about what the agency ob­ject­ed to.

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