European regulators have approved Amgen’s Parsabiv (etelcalcetide), licensing it for secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
The first new treatment to be approved for sHPT in more than a decade, Parsabiv is also an important product for the company as it provides a follow-up to its Sensipar/Mimpara blockbuster.
The European Commission’s decision, whilst expected, will be welcome news for Amgen as it follows the FDA’s decision not to approve the drug in August.
Prior to that Parsabiv had been predicted to equal and potentially exceed Sensipar, which brought in more than $1.4bn last year, although it is starting to face generic competition in some markets.
Amgen says Sensipar only has around 25% market penetration, mainly because of compliance issues associated with the need to dose the tablets orally every day. In contrast, Parsabiv is administered as an infusion during dialysis, side-stepping the compliance issue.
Clinical trials have suggested Parsabiv is as good as Sensipar in reducing parathyroid hormone levels in sHPT, and more effective than Sensipar in terms of the number of patients experiencing high-level responses.
Sean Harper, executive vice president of research and development at Amgen, said: “Treatment adherence can be a challenge with any oral medicine, if poorly controlled, sHPT may progress and can have significant clinical consequences.
“With Parsabiv, we can put the delivery of the therapy in the hands of the healthcare provider and help ensure that these patients receive this important treatment as part of their dialysis session three times a week.”
There are around two million people worldwide who are on dialysis as a result of kidney failure and, as sHPT is a frequent complication, analysts have said Parsabiv has significant sales potential.
Amgen picked up rights to the drug when it acquired Kai Pharmaceuticals for $315m in 2012.