OPKO Health Says FDA Accepts Its Resubmission Of NDA For Its RAYALDEE

OPKO Health, Inc.

disclosed that the FDA in the United States accepted its resubmission of the New Drug Application (NDA) for its RAYALDEE (calcifediol) on April 22. The company said that the drug candidate was for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. OPKO indicated that it resubmitted the NDA after the receipt of a complete response letter (CRL) from the FDA on March 29, 2016, in which the regulator indicated the NDA could not be approved due to deficiencies observed during a facility inspection of OPKO's third party manufacturer. The company said that the observations were not specific to RAYALDEE manufacturing, and that the CRL did not point out any safety, efficacy or labeling issues in respect of RAYALDEE, nor did it request any additional studies to be conducted before the FDA approval. The drug firm said that a six month review period was assigned for the resubmitted NDA, and that the new Prescription Drug User Fee Act (PDUFA) date would be October 22. OPKO' Chairman and CEO, Phillip Frost, commented, "We have worked closely with our third party manufacturer to ensure the FDA's inspection observations are promptly and fully addressed, and we believe that our resubmission reflects OPKO's strong commitment to providing a new treatment for SHPT in CKD patients as soon as possible. If approved, RAYALDEE will be the first drug approved for this important indication." Shares of the company traded 0.9% down on Wednesday.