July 18, 2011
Shire plc: LialdaÂ® (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
PHILADELPHIA, July 18, 2011 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that the U.S. Food and Drug
Administration (FDA) approved Lialda(R) (mesalamine) Delayed Release Tablets
for the maintenance of remission in patients with ulcerative colitis. This
approval is based on results from a six-month study demonstrating the safety
and effectiveness of Lialda in maintaining endoscopic remission in adult
patients. This approval follows the previous indication of Lialda approved
by the FDA in 2007 for the induction of remission in patients with active,
mild to moderate ulcerative colitis.
"At Shire, we strive to create meaningful therapies for patients with
our clinical programs, and this approval based on our large clinical trial
underscores our commitment and dedication to the ulcerative colitis
community," said Roger Adsett, Senior Vice President of Shire's
Gastrointestinal business. "This new indication is an important milestone
for Lialda as it provides a once-daily option for both inducing remission in
patients with active, mild to moderate ulcerative colitis and maintaining
remission of ulcerative colitis."
Lialda's new indication is based on results from a multicenter,
randomized, double-blind, active comparator, non-inferiority study conducted
in 826 adult patients in remission from ulcerative colitis. Maintenance of
remission was assessed using a modified Ulcerative Colitis Disease Activity
Index (UC-DAI) and was based on maintaining endoscopic remission defined as
a modified UC-DAI endoscopy subscore of less than or equal to 1. The
endoscopy subscore of less than or equal to 1 represented normal or mild
disease with no friability.
Of the patients receiving Lialda 2.4 g/day (n=343) administered once
daily, 83.7% maintained remission at Month 6, which was similar to that seen
using the comparator, mesalamine delayed-release 1.6 g/day (n=336)
administered as 0.8 g given twice daily (81.5%; 95% confidence interval for
difference: -3.9%, 8.1%).
Safety of Lialda in the maintenance of remission of ulcerative colitis
was evaluated in three studies, one being the six-month, double-blind,
non-inferiority, comparator study and two being 12- to 14-month open-label
studies. The most common adverse reactions with Lialda in the maintenance
arms of these three trials were ulcerative colitis, headache, abnormal liver
function test and abdominal pain. The most common severe adverse reactions
were gastrointestinal disorders, most of which are consistent with symptoms
associated with ulcerative colitis.
In 2007, Lialda gained FDA approval for the induction of remission in
patients with active, mild to moderate ulcerative colitis as a result of two
eight-week, placebo-controlled clinical studies demonstrating safety and
Important Safety Information
You should not take Lialda if you are allergic to salicylates (including
mesalamine, aspirin, or aspirin-containing products) or to any of the
ingredients of Lialda.
Reports of problems with kidney function have been associated with
mesalamine-containing products like Lialda. Tell your doctor if you have or
have had problems with your kidneys. It is recommended that all patients
have their kidney function checked before starting Lialda and periodically
while on therapy.
Products that contain mesalamine, like Lialda, have been associated with
a condition that may be difficult to distinguish from an ulcerative colitis
flare-up. Symptoms include cramping, stomach ache, bloody diarrhea, fever,
headache, and rash. If you experience any of these symptoms, talk to your
doctor immediately. Your doctor may decide to discontinue your medication.
Tell your doctor if you are allergic to sulfasalazine, as you may also
be allergic to Lialda or drugs that contain or are converted to mesalamine.
Some patients taking Lialda or mesalamine-containing products have reported
heart-related allergic reactions, such as inflammation of the heart muscle
and inflammation of the lining of the heart. Tell your doctor if you have or
have had a history of myocarditis or pericarditis as this may predispose you
to these types of reactions.
Reports of liver failure have been associated with mesalamine-containing
products like Lialda in patients that have or have had liver disease. Tell
your doctor if you have a problem with your liver.
Tell your doctor if you have a stomach blockage, as this may delay the
release of medication.
In clinical trials, common side effects reported with Lialda included
ulcerative colitis, headache, gas, abnormal liver function test results, and
stomach ache. Inflammation of the pancreas was reported which in some cases
led to discontinuation of Lialda therapy. Other side effects may occur.
Before starting Lialda, tell your doctor about all medications you are
taking. Mesalamine may increase the risk of kidney problems when used with
non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen).
Mesalamine may increase the risk of blood disorders when used with
azathioprine and 6-mercaptopurine.
Please see Full Prescribing Information.
Additional information about Lialda is available at
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit http://www.FDA.gov/medwatch, or call 1-800-FDA-1088.
Lialda is indicated for the induction of remission in patients with
active, mild to moderate ulcerative colitis and for the maintenance of
remission of ulcerative colitis. Lialda is available as a delayed-release
tablet containing 1.2 g mesalamine. For the induction of remission in
patients with active, mild to moderate ulcerative colitis, the recommended
dosage is two or four 1.2 g tablets taken once daily with a meal. The
recommended dosage for the maintenance of remission of ulcerative colitis is
two 1.2 g tablets taken once daily with a meal.
About Ulcerative Colitis
Ulcerative colitis is a type of inflammatory disease. It only affects
the colon, producing chronic inflammation and sometimes sores or ulcers
along the inside lining of the colon. It is characterized by diarrhea, which
is generally bloody, and often painful cramping in the abdomen. Currently,
there is no cure available with medical treatment, and the cause of the
disease is unknown.
Notes to editors
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
For further information on Shire, please visit the Company's website:
"SAFEHARBOR" 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 Pharmaceuticals 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.
For further information please contact:
Matthew Cabrey ([email protected]) +1-484-595-8248 Ingrid Jansen ([email protected]) +32-14-404-360 Meredith Butler ([email protected]) (GolinHarris for Shire) +1-919-381-6936
SOURCE Shire plc