Post by gutset on Nov 25, 2016 13:59:25 GMT
www.investopedia.com/news/opko-health-ships-rayaldee-kidney-drug-us-opk/#ixzz4R1q8cl6K
By Shobhit Seth | November 24, 2016 — 7:18 PM EST
Opko Health Inc. (OPK) launched Rayaldee (calcifediol) extended-release capsules for kidney disease in the U.S.
Shipments to distributors will start November 29, and the medicine will be available in pharmacies across the country starting November 30. (For more, see The Synergy From Opko's Acquisition of Transition Therapeutics.)
Rayaldee, which treats secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, secured approval from the Food And Drug Administration (FDA) in June 2016. It remains the only approved drug in the U.S. for hyperparathyroidism.
The chronic kidney disease drug works by raising serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels of at least 30 ng/mL and by reducing elevated intact parathyroid hormone.
Chronic Kidney Disease Market
Chronic kidney disease (CKD) refers to a progressive decline in kidney function. CKD is classified in five stages (stage 1 to 5) which are in increasing order of severity.
Secondary hyperparathyroidism (SHPT) is a disorder linked to CKD, which results from vitamin D deficiency or impaired kidney function that prevents sufficient production of vitamin D hormone.
SHPT is estimated to impact 40% to 60% of patients suffering from moderate CKD (stage 3 or 4) and approximately 90% of patients with severe CKD (stage 5).
Overall, CKD affects 26 million individuals in the US. Around 20 million of those people suffer from stage 3 or 4 CKD. Opko’s Rayaldee is approved for treating SHPT in patients with stage 3 or stage 4 CKD.
By Shobhit Seth | November 24, 2016 — 7:18 PM EST
Opko Health Inc. (OPK) launched Rayaldee (calcifediol) extended-release capsules for kidney disease in the U.S.
Shipments to distributors will start November 29, and the medicine will be available in pharmacies across the country starting November 30. (For more, see The Synergy From Opko's Acquisition of Transition Therapeutics.)
Rayaldee, which treats secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease, secured approval from the Food And Drug Administration (FDA) in June 2016. It remains the only approved drug in the U.S. for hyperparathyroidism.
The chronic kidney disease drug works by raising serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels of at least 30 ng/mL and by reducing elevated intact parathyroid hormone.
Chronic Kidney Disease Market
Chronic kidney disease (CKD) refers to a progressive decline in kidney function. CKD is classified in five stages (stage 1 to 5) which are in increasing order of severity.
Secondary hyperparathyroidism (SHPT) is a disorder linked to CKD, which results from vitamin D deficiency or impaired kidney function that prevents sufficient production of vitamin D hormone.
SHPT is estimated to impact 40% to 60% of patients suffering from moderate CKD (stage 3 or 4) and approximately 90% of patients with severe CKD (stage 5).
Overall, CKD affects 26 million individuals in the US. Around 20 million of those people suffer from stage 3 or 4 CKD. Opko’s Rayaldee is approved for treating SHPT in patients with stage 3 or stage 4 CKD.
