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June 23, 2014
14:01 EDTOPKOPKO Health reports positive interim six-month Lagova Phase 2 data
OPKO Health announced 6 month results of a Phase 2 dose-finding study evaluating the safety and efficacy of its novel long-acting human growth hormone product to treat pediatric growth hormone deficiency disorder. All three Lagova once-weekly doses demonstrate strong catch-up growth during the six months treatment. The annualized growth rates are above 12 cm in all three doses. The results are supported by excellent dose dependent pharmacokinetics and pharmacodynamics profiles. Lagova shows a promising safety profile with no serious adverse events reported. Glucose and lipid metabolism markers are within the normal ranges. No lipoatrophy was observed in any patients dosed, and no clinically significant local tolerability issues were identified. “Based on these encouraging safety and efficacy results, OPKO plans to move aggressively into a single confirmatory pivotal Phase 3 study for pediatric GHD patients. We hope to make Lagova available to pediatric GHD patients as soon as possible,” said CEO, Phillip Frost, M.D. “Lagova is one of a family of important products being developed at OPKO Biologics designed to improve compliance and offer ease of administration to patients.”
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July 28, 2015
13:43 EDTOPKOPKO Health announces FDA acceptance of NDA for Rayaldee
OPKO Health announced that the U.S. FDA has accepted for review OPKO’s New Drug Application for calcifediol modified-release capsules, proposed trade name, Rayaldee. In the NDA, OPKO seeks approval of Rayaldee for the prevention and treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. OPKO expects written notification of NDA acceptance along with the Prescription Drug User Fee Act date in the FDA’s 74-Day letter, which the company expects to receive by mid-August 2015. The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. These studies met all primary efficacy and safety endpoints, as previously announced.

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