- Opko Health this week won U.S. approval for its kidney disease drug Rayaldee, overcoming a manufacturing issue at its third-party contractor Catalent which had prompted the Food and Drug Administration to issue a complete response letter for the drug.
- The manufacturing setback was unrelated to Rayaldee but still resulted in a nearly three-month delay for Opko.
- Rayaldee treats a kidney condition known as secondary hyperparathyroidism (SHPT), which is commonly associated with chronic kidney disease. Opko plans to launch Rayaldee in the second half of this year, with a dedicated sales force of around 25 sales representatives, although the company plans to expand that number.
Opko is an established maker of diagnostics, but this is their first drug to market. Development of Rayaldee began around a decade ago and Opko hopes the drug will be an important option for treating SHPT earlier on in disease progression.
The overall market for SHPT and late stage chronic kidney disease could be as high as $12 billion, Opko estimates. Rayladee while face some competition from Big Pharma, however. Amgen's Sensipar is currently a common treatment option for SHPT in patients with kidney disease and on dialysis. It brought in a little over $1.4 billion last year.
And NPS Pharma (now part of Shire) won approval last year for Natpara, which treats a related condition.
This is the second time that Opko submitted Rayaldee to the FDA. In March, the FDA issued a complete response letter due to manufacturing issues at a Catalent manufacturing facility which Opko had contracted to make Rayaldee.
A field inspection had cited a number of deficiencies at the plant, although none were specific to the safety or efficacy of Rayaldee. Catalent addressed the issues quickly and Opko resubmitted for approval in late April.
Rayaldee is the first drug to use Catalent's new softgel capsule technology, known as Optishell, which uses a plant-based shell to encapusulate semi-solid fill material.
The FDA's positive decision comes three months ahead of Rayaldee's October 22 PDUFA date.