The FDA has slapped a complete response letter onto Amgen ($AMGN) for its experimental med to treat a hormonal imbalance in dialysis patients, dashing its hopes of a 2016 approval.
The NDA Amgen was seeking was for its candidate Parsabiv (etelcalcetide) in patients with secondary hyperparathyroidism (sHPT) with chronic kidney disease on hemodialysis.
In a very brief update, Amgen said the FDA has rejected it application in its current form, but gave no details as to whether this was due to concerns over safety, manufacturing of efficacy.
The nature of the letter, and especially if it required additional clinical trials, could seriously delay any approval of the med. Amgen said in a statement that it was “reviewing the Complete Response Letter, and we anticipate a post-action meeting with the FDA later this year to discuss the Complete Response.”
The FDA does not have to publicly declare the reason for its rejection, and companies can wait to make this information available. It filed the drug for U.S. review back in September, and in the same month with the EMA.
Amgen added that this wouldn’t affect other regulatory submissions, but this may well depend on the issue or issues the FDA has found, and whether that will impact the drug’s other reviews.
Parsabiv works as calcimimetic agent, a drug designed to mimic the action of calcium by activating the calcium-sensing receptors on the parathyroid gland. Parsabiv, which is given intravenously, binds to and activates the calcium-sensing receptor on the parathyroid gland, decreasing PTH levels.
Amgen gained access to the drug four years ago as part of its $315 million acquisition of KAI Pharmaceuticals. In three Phase III trials posted last year, the drug met its primary goals by significantly reducing parathyroid hormone levels.
Amgen had hoped that its new med would supplant sales of its older treatment for the condition Sensipar (cinacalcet), which last year reached blockbuster sales. Analysts have previously suggested that Parsabiv could match Sensipar's sales at peak.
sHPT is a chronic and serious condition which, Amgen estimates, affects around 2 million people worldwide on dialysis, with about half a million of these in the U.S.
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