MEDIA RELEASE PR36805
Shire Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease
DUBLIN, Oct. 28 /PRNewswire-AsiaNet/ -
- FOSRENOL(R) (lanthanum carbonate) now approved in the EU to treat
hyperphosphataemia >1.78mmol/L in chronic kidney disease patients not on
dialysis
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced it has received approval through
the European Mutual Recognition Procedure for an extension to the current
indication for FOSRENOL(R) (lanthanum carbonate), paving the way to make the
non-calcium, non-resin phosphate binder available throughout the EU to
control hyperphosphataemia in chronic kidney disease (CKD) patients who are
not on dialysis with a serum phosphorus level greather than or equal to
1.78mmol/L (5.5mg/dL).
The extension was sanctioned by the Swedish Medicines Products
Agency as reference member state. Submissions for national marketing
authorizations have been made to Sweden and the other 28 European markets
with first national approvals anticipated in Q4 2009.
"Failure to control phosphate in the earlier stages of chronic kidney
disease carries well documented risks, and is associated with reduced bone
health and poor cardiovascular outcomes," said Dr. Alastair Hutchison,
Manchester Royal Infirmary, UK. "The extension to the existing indication for
FOSRENOL provides nephrologists in the EU with an important additional option
to help tackle the challenge of uncontrolled phosphate at an earlier stage in
the progression of kidney disease, before the need for dialysis treatment."
"This is an important development in helping CKD patients
better manage their elevated phosphate and we are pleased that FOSRENOL is
now approved as a treatment option for these patients in the EU," said Gian
Piero Reverberi, Senior Vice President, International Specialty
Pharmaceuticals, Shire. "We are firmly committed to serving the needs of
renal patients and ensuring that FOSRENOL is available to the prescribers and
patients who can benefit from it."
In relation to the US, Shire continues to evaluate its options
for securing a label extension to include CKD patients not on dialysis.
Notes to Editors
ABOUT FOSRENOL(R) (lanthanum carbonate)
FOSRENOL is indicated:
- In the EU as a phosphate binding agent for use in the control of
hyperphosphataemia in chronic renal failure patients on haemodialysis
or continuous ambulatory peritoneal dialysis. FOSRENOL is also
indicated in adult patients with chronic kidney disease not on dialysis
with serum phosphate levels greater than or equal to 1.78 mmol/L in
whom a low phosphate diet alone is insufficient to control serum
phosphate levels.(1)
- In the US to reduce serum phosphate in patients with end stage renal
disease.(2)
- FOSRENOL is not available in all countries and prescribing information
may differ between countries. Please consult your local prescribing
information.(2)
- FOSRENOL works by binding to dietary phosphate in the GI tract; once
bound, the lanthanum/phosphate complex cannot pass through the
intestinal lining into the blood stream and is eliminated from the
body.(1) As a consequence, overall phosphate absorption from the diet
is decreased.
- FOSRENOL is available in a broad range of dosage strengths including
500mg, 750mg, and 1000mg tablets1 which facilitates an effective dosing
regimen of one tablet per meal for the majority of patients.
- FOSRENOL was first approved in Sweden in March 2004, and by the US FDA
in October 2004. FOSRENOL was subsequently approved in all EU markets
by the European Mutual Recognition Procedure and is now launched in 37
markets worldwide. It continues to be approved and made available in
new markets around the world.
Important Safety Information
- Patients with renal insufficiency may develop hypocalcaemia. Serum
calcium levels should therefore be monitored at regular time intervals
for this patient population and appropriate supplements given.
- No data are available in patients with severe hepatic impairment.
Caution should, therefore, be exercised in these patients, as
elimination of absorbed lanthanum may be reduced.
- FOSRENOL should not be used during pregnancy.
- Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease
or bowel obstruction were not included in clinical studies with
FOSRENOL.
- The most commonly reported Adverse Drug Reactions are gastrointestinal
reactions, such as abdominal pain, constipation, diarrhoea, dyspepsia,
flatulence, nausea and vomiting. These are minimized by taking FOSRENOL
with food and generally abate with time with continued dosing.
Hypocalcaemia was the only other commonly reported adverse reaction.
Full prescribing information is available on request.
References
(1) Shire plc. FOSRENOL EU SmPC. Last revised September 2009.
(2) Shire plc. FOSRENOL US PIL. Last revised April 2008.
SHIRE PLC
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit hyperactivity
disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases as well as opportunities in other therapeutic areas to the extent
they arise through acquisitions. Shire's in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes that a
carefully selected and balanced portfolio of products with strategically
aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a number
of risks and uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, the Company's results could be
materially adversely affected. The risks and uncertainties include, but are
not limited to, risks associated with: the inherent uncertainty of research,
development, approval, reimbursement, manufacturing and commercialization of
the Company's Specialty Pharmaceutical and Human Genetic Therapies products,
as well as the ability to secure and integrate new products for
commercialization and/or development; government regulation of the Company's
products; the Company's ability to manufacture its products in sufficient
quantities to meet demand; the impact of competitive therapies on the
Company's products; the Company's ability to register, maintain and enforce
patents and other intellectual property rights relating to its products; the
Company's ability to obtain and maintain government and other third-party
reimbursement for its products; and other risks and uncertainties detailed
from time to time in the Company's filings with the Securities and Exchange
Commission.
SOURCE: Shire Plc
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