Amgen Files NDA, Seeks FDA Approval For Parathyroid Drug
Today Amgen (AMGN) has announced that it has filed for FDA approval for its drug, etelcalcetide, in patients for parathyroid problems caused by Chronic Kidney disease (CKD). More specifically the disease is known as Secondary Hyperparathyroidism -- SHPT. This disease leads to patients having frail bones, muscle pain, and organ damage after dialysis.
SHPT is where there is an excessive secretion of the parathyroid hormone by the parathyroid glands. The reason for this is that the body is trying to make up for the loss of blood calcium levels in the body.
Currently patients are hugely impacted by SHPT because they have to take a bundle of pills for treatment. If etelcalcetide is approved it would be administered to patients intravenously directly after dialysis. Patients with CKD have to go three times a week to receive dialysis anyway, so receiving an additional intravenous solution directly afterwards should be more convenient than taking a bunche of pills every day of the week.
The NDA was filed with data from three phase 3 studies where the etelcalcetide drug met on the primary endpoint of each trial.
In other news, Amgen also announced that it will give a long-term trial update on its cardiovascular drug Repatha, which is used for patients with bad cholesterol. This update will be given at the European Society of Cardiology Congress 2015. Repatha is already approved in Europe for patients with uncontrolled cholesterol levels who can't tolerate statins.
Shares of Amgen ended the day down 1% after announcing both pieces of news today.
Disclosure: None.