OPK
OPKO HEALTH Inc
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FDA Accepts Resubmission of New Drug Application for RAYALDEE

MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK) today announced 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.

“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”

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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. The observations were not specific to RAYALDEE manufacturing, and the CRL did not cite any safety, efficacy or labeling issues with regard to RAYALDEE, nor did it request any additional studies to be conducted prior to FDA approval.

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.

"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,” stated Phillip Frost, M.D., Chairman and CEO of OPKO. “If approved, RAYALDEE will be the first drug approved for this important indication.”

About RAYALDEE

RAYALDEE (calcifediol) extended-release capsules are pending approval by the U.S. Food and Drug Administration (FDA) for the treatment of SHPT in adult patients with stage 3 or 4 CKD and vitamin D insufficiency. RAYALDEE has a proprietary formulation designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated intact parathyroid hormone (iPTH). RAYALDEE is presently expected to be launched in the U.S. by OPKO's dedicated sales force in 4Q 2016.

About Chronic Kidney Disease

CKD is a condition characterized by a progressive decline in kidney function. The kidney is normally responsible for excreting...


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