OPKO Health, Inc. (NASDAQ:OPK) today announced that the Kidney
Disease Improving Global Outcomes (KDIGO) organization has updated
its Clinical Practice Guideline for the Diagnosis, Evaluation,
Prevention and Treatment of Chronic Kidney Disease-Mineral and Bone
Disorder (CKD-MBD).
(http://kdigo.org/wp-content/uploads/2017/02/2017-KDIGO-CKD-MBD-GL-Update.pdf)
The update amends the 2009 KDIGO Clinical Practice Guideline and
presents revised positions on current standards of care for the
treatment of secondary hyperparathyroidism (SHPT) in patients with
CKD stages 3 or 4:
- Calcitriol and (1α-hydroxylated) vitamin D
analogs: These therapies are no longer suggested for
routine use and should be reserved for patients with stage 4 or 5
CKD with severe and progressive hyperparathyroidism. The
guideline notes that recent randomized clinical trials of
calcitriol and its analogs failed to demonstrate improvements in
outcomes but demonstrated increased risk of hypercalcemia, leading
KDIGO to conclude that the risk-benefit ratio was no longer
favorable for routine usage in patients with stage 3 or 4
CKD.
- Nutritional vitamin D: Supplementation with
ergocalciferol or cholecalciferol remains unproven as a treatment
for SHPT.
The updated guideline acknowledges Rayaldee® (extended release
calcifediol) as a novel vitamin D prohormone and mentions that it
both increases serum levels of 25-hydroxyvitamin D and lowers PTH
in patients with stage 3 or 4 CKD. Developed by OPKO Health,
Rayaldee is the first and only FDA-approved extended-release
prohormone to treat SHPT and it has a safety profile similar to
that of placebo.1
“The updated guideline represents a needed shift in the way
nephrologists manage secondary hyperparathyroidism in patients with
stage 3 or 4 chronic kidney disease,” said Michael J.
Germain, MD, Professor of Medicine, Tufts University School of
Medicine and Nephrologist/Partner, Western New England Renal &
Transplant Associates, PC, Springfield, MA. “SHPT is one of
the most common complications of CKD and, unfortunately, it has
also been historically difficult to treat due to a lack of an
effective and appropriate, FDA-approved treatment option.
Having this updated guidance and the availability of an
option like Rayaldee are significant advancements for both patients
and providers managing this complex disease.”
“The updated KDIGO guideline highlights the unmet needs that
exist in the treatment of SHPT, and we are working with physicians
and other health care professionals to address these needs with
Rayaldee,” said Charles W. Bishop, PhD, CEO of the OPKO Health
Renal Division.
About Rayaldee
Rayaldee is indicated for the treatment of secondary
hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and
vitamin D insufficiency, defined as serum total 25-hydroxyvitamin D
less than 30 ng/mL. It is not indicated in patients with
stage 5 chronic kidney disease or end-stage renal disease on
dialysis.2
Potential side effects of Rayaldee include hypercalcemia
(elevated serum calcium), which can also lead to digitalis
toxicity, and adynamic bone disease with subsequent increased risk
of fractures if intact PTH levels are suppressed by Rayaldee to
abnormally low levels. Severe hypercalcemia may require emergency
attention; symptoms of hypercalcemia may include feeling tired,
difficulty thinking clearly, loss of appetite, nausea, vomiting,
constipation, increased thirst, increased urination, and weight
loss. Digitalis toxicity can be potentiated by hypercalcemia of any
cause. Excessive administration of Rayaldee can cause
hypercalciuria, hypercalcemia, hyperphosphatemia, or
oversuppression of intact PTH. Common symptoms of vitamin D
overdosage may include constipation, decreased appetite,
dehydration, fatigue, irritability, muscle weakness, or vomiting.
Patients concomitantly taking cytochrome P450 inhibitors,
thiazides, cholestyramine, phenobarbital or other anticonvulsants
may require dose adjustments and more frequent monitoring.
The most common adverse reactions in clinical trials (≥3% and
more frequent than placebo) were anemia, nasopharyngitis, increased
blood creatinine, dyspnea, cough, congestive heart failure and
constipation.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company that seeks to
establish industry leading positions in large, rapidly growing
markets. Our diagnostics business includes BioReference
Laboratories, the nation's third largest clinical laboratory with a
core genetic testing business and a 400 person sales and marketing
team to drive growth and leverage new products, including the
4Kscore® prostate cancer test and the Claros® 1 in office
immunoassay platform. Our pharmaceutical business features
RAYALDEE, an FDA approved treatment for SHPT in stage 3-4 CKD
patients with vitamin D insufficiency (launched in November 2016),
VARUBITM for chemotherapy induced nausea and vomiting (oral
formulation launched by partner TESARO and IV formulation pending
FDA approval), OPK88004, a once or twice weekly oxyntomodulin for
type 2 diabetes and obesity, in Phase 2 clinical trials, among the
new class of GLP-1 glucagon receptor dual agonists, and OPK88003,
a selective androgen receptor modulator for benign prostatic
hyperplasia (Phase 2). Our biologics business includes hGH-CTP, a
once weekly human growth hormone in Phase 3 and partnered with
Pfizer; and a long-acting Factor VIIa drug for hemophilia in Phase
2a. More information available at www.opko.com.
Cautionary Statement Regarding Forward-Looking
Statements This press release contains
"forward-looking statements," as that term is defined under the
Private Securities Litigation Reform Act of 1995 (PSLRA), which
statements may be identified by words such as "expects," "plans,"
"projects," "will," "may," "anticipates," "believes," "should,"
"intends," "estimates," and other words of similar meaning,
including statements regarding the benefits of RAYALDEE, its
ability to increase both serum levels of 25-hydroxyvitamin D and
1,25-dihydroxyvitamin D and lower parathyroid hormone, whether
RAYALDEE will fill a treatment gap in treatment of SHPT, as well as
other non-historical statements about our expectations, beliefs or
intentions regarding our business, technologies and products,
financial condition, strategies or prospects. Many factors could
cause our actual activities or results to differ materially from
the activities and results anticipated in forward-looking
statements. These factors include those described in our Annual
Report on Form 10-K filed with the Securities and Exchange
Commission and in our other filings with the Securities and
Exchange Commission. The forward-looking statements contained in
this press release speak only as of the date the statements were
made, and we do not undertake any obligation to update
forward-looking statements. We intend that all forward-looking
statements be subject to the safe-harbor provisions of the
PSLRA.
1 Sprague SM, Crawford PW, Melnick JZ, et al. Use of
extended-release calcifediol to treat secondary hyperparathyroidism
in stages 3 and 4 chronic kidney disease. Am J Nephrol. 20 l
6;44:316-325.2 Rayaldee [prescribing information]. Miami, FL:
OPKO Pharmaceuticals, LLC; July 2016.
Contacts:
OPKO Health Tara Mackay, 305-575-4100tmackay@opko.comorDavid
Malina, 305-575-4137DMalina@opko.com Investor Relations
or
Media Rooney Partners Terry Rooney,
212-223-0689trooney@rooneyco.comorMarion Janic,
212-223-4017mjanic@rooneyco.com
or
Investors LHA Investor Relations Anne Marie Fields,
212-838-3777afields@lhai.com orBruce Voss,
310-691-7100bvoss@lhai.com
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