An open-label extension trial to evaluate the long-term efficacy and safety of CTAP 101 to treat secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease and vitamin D insufficiency
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 21 Jun 2016
At a glance
- Drugs Calcifediol (Primary)
- Indications Hyperparathyroidism
- Focus Registrational; Therapeutic Use
- Sponsors OPKO Renal
- 21 Jun 2016 According to an OPKO Health media release, the US FDA has approved RAYALDEE (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. The approval was based on two phase III trials (700238767 and 238771) and an open-label extension study (700238773).
- 27 Apr 2016 According to an OPKO Health media release, the U.S. Food and Drug Administration (FDA) has accepted OPKO's resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE (calcifediol) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
- 27 Apr 2016 OPKO resubmitted the NDA following receipt of a complete response letter (CRL) from the FDA on March 29, 2016, in which the FDA indicated the NDA could not be approved due to deficiencies observed during a facility inspection of OPKO's third party manufacturer. A six month review period has been assigned for the resubmitted NDA, and the new Prescription Drug User Fee Act (PDUFA) date will be October 22, 2016.