- The Food and Drug Administration has approved a drug from Amgen designed to regulate a specific group of hormones in patients with chronic kindey disease (CKD) undergoing dialysis, ending a more than 10-year drought for new treatments in that indication.
- The drug, Parsabiv (etelcalcetide), treats patients with secondary hyperparathyroidism (SHPT), a frequent byproduct of CKD. As the name suggests, SHPT leads to higher levels of parathyroid hormones — molecules responsible for regulating calcium in the blood stream. Notably, patients can receive the drug intravenously.
- "Parsabiv not only has demonstrated strong efficacy in clinical trials; it also fills an unmet need by putting the delivery of the therapy in the hands of the health care professional," Sean Harper, head of Amgen's R&D arm, said in a Tuesday statement.
Amgen is also responsible for the last drug approved to treat this specific patient population, Sensipar (cinacalcet), which got the greenlight from the FDA in 2004. The monthly price tag should be similar depending on dose for the two drugs, the company said in its Feb. 7 statement.
The wholesale acquisition price for a once-daily 30mg dose of Sensipar is $800 per month, Amgen said in an email.
The FDA's approval is timely, given that Sensipar faces generic competition. As of Sept. 30, the company was involved in 12 lawsuits claiming patent infringement of its drug. The lawsuits were aimed at generic drugmakers, including Aurobindo, Sun Pharma and Amneal Pharmaceuticals.
Interest in hyperparathyroidism drugs isn't surprising, though, given the potential market. Sensipar brought in $411 million for Amgen during the fourth quarter, despite its age. Other players have received approval for similar drugs as well, such as Opko Health's Rayaldee (calcifediol), which aims to treat SHPT in adults who have stage 3 or 4 CKD.
Parsabiv's approval comes after strong efficacy results in three late-stage studies that tested more than 1,700 patients with CKD who were receiving kidney dialysis.
Two placebo-controlled Phase 3 trials showed that nearly three-in-four patients taking Parsabiv had parathyroid hormone levels reduced by at least 30% from baseline — the primary endpoint for the study — versus 8.9 percent for patients who received placebo. Amgen also ran the drug through a Phase 3 study comparing the drug to Sensipar. Both treatments had similar efficacy, the study found.
While the main adverse effects seen in those late-stage trials were muscle spasms, nausea, vomiting and low calcium levels in the blood, more series effects such as worsening heart failure were also common (seen in more than 1% of patients) and higher for those receiving Parsabiv versus placebo (2.2% compared to 1.2%, respectively).