FDA Approves OPKO’s Rayaldee

On June 21, 2016 FDA approved OPKO Health’s Rayaldee (calcifediol), an extended-release capsule for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 kidney disease and serum total 25-hydroxyviatamin D levels less than 30 nj/mL. Rayaldee is the first product to receive FDA approval for this indication, the company noted in a press statement.

Results of Phase III trials with the drug demonstrated that Vitamin D insufficiency was corrected in more than 80% patients. In addition, patients taking Rayaldee achieved more than 30% reductions in plasma intact parathyroid hormone compared with the placebo. OPKO expects the drug to be available to patients in the United States during the second half of 2016.

Rayaldee is manufactured using Catalent’s proprietary OptiShell softgel capsule technology as its extended-release delivery platform, which allows for high-temperature encapsulation of semi-solid fill material with a non-gelatin, plant-based shell. According to Catalent, OptiShell capsules utilize a patented shell derived from plant polysaccharides and are suited for the encapsulation of higher melting-point fill formulations, like Rayaldee. Rayaldee capsules will be manufactured at Catalent’s facility in St. Petersburg, Florida.

Source: OPKO, Catalent