Cambridge, Mass. – January 22, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that data will be presented on GATTEX® / REVESTIVE®▼ (teduglutide [rDNA origin]) for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support (PS)1,2 at the ASPEN 2018 Nutrition Science & Practice (formerly Clinical Nutrition Week), in Las Vegas, Nev., January 22-25, 2018.
The data are post-hoc analyses from the pivotal STEPS study,3 examining potential factors affecting the relationship between GATTEX / REVESTIVE and the reduction of parenteral support (PS) volume. The poster presentations of these data are titled:
“Shire is pleased to be able to add to the body of knowledge regarding the treatment of short bowel syndrome, a rare condition which can have a considerable impact on patients,” said Howard Mayer, Chief Medical Officer, Shire. “We remain committed to serving patients with rare diseases and we are proud to support a variety of activities to help people with SBS worldwide.”
In addition to the presentation of the data, Shire is a proud sponsor of the ASPEN meeting.
About Short Bowel Syndrome with Intestinal Failure
SBS is a rare and potentially life-threatening gastrointestinal condition.6 It is characterized by a clinically significant reduction in intestinal absorptive capacity,7,8 as a consequence of surgical resection of large portions of the intestine commonly due to congenital abnormalities, disease or trauma.7 If intestinal adaptation is inadequate, the absorptive capacity of the residual intestine becomes insufficient to meet the nutritional, fluid and electrolyte needs9,10,11; this leads to intestinal failure, which requires chronic dependence on PS to maintain adequate hydration, protein, electrolyte and micronutrient balances.7,11
About GATTEX / REVESTIVE
GATTEX / REVESTIVE contains the active substance teduglutide, a glucagon-like peptide-2 (GLP-2) analogue.1,2
In the United States, GATTEX (teduglutide [rDNA origin]) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome who are dependent on Parenteral Support.1
In Europe, REVESTIVE is indicated for the treatment of patients aged one year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.2 REVESTIVE received Market Authorization in Europe in 2012 for the treatment of adult patients with SBS, who should be stable following a period of intestinal adaptation after surgery. The European Commission extended the REVESTIVE license for treatment of SBS patients aged one year and above in July 2016.12
REVESTIVE (teduglutide for injection) is currently indicated in Canada for the treatment of adult patients with Short Bowel Syndrome who are dependent on Parenteral Support.13
US GATTEX Important Safety Information1
What is the most important information I should know about GATTEX?
GATTEX may cause serious side effects, including:
Making abnormal cells grow faster
GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gallbladder or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX.
Polyps in the colon (large intestine)
Polyps are growths on the inside of the colon. Polyps were found in patients taking GATTEX in clinical studies. Your healthcare provider will have your colon checked for polyps within 6 months before starting GATTEX and have any polyps removed.
To keep using GATTEX, your healthcare provider should have your colon checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 years and have any new polyps removed. If cancer is found in a polyp, your healthcare provider should stop GATTEX.
Blockage of the bowel (intestines)
A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Bowel blockage was reported in patients taking GATTEX in clinical studies. Tell your healthcare provider if you have any of these symptoms of a bowel blockage:
If blockage is found, your healthcare provider may temporarily stop GATTEX.
Swelling (inflammation) or blockage of your gallbladder or pancreas
Swelling or blockage of the gallbladder or pancreas were reported in patients taking GATTEX in clinical studies. Your healthcare provider will do tests to check your gallbladder and pancreas within 6 months before starting GATTEX and at least every 6 months while you are using GATTEX. Tell your healthcare provider right away if you get stomach area (abdomen) pain and tenderness, chills, fever, change in your stools, nausea, vomiting, dark urine, or yellowing of your skin or the whites of eyes.
Fluid overload and heart failure were reported in patients taking GATTEX in clinical studies. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Your healthcare provider will check you for too much fluid in your body. Tell your healthcare provider if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing.
The most common side effects of GATTEX include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
What should I tell my healthcare provider before using GATTEX?
Tell your healthcare provider if you:
Tell your healthcare providers about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other causing side effects. Your other healthcare providers may need to change the dose of any oral medicines you take while using GATTEX. Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional safety information, please click here for the US Full Prescribing Information and discuss with your doctor.
International REVESTIVE Safety Information2
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system [found under section 4.8 of the SmPC].
Hypersensitivity to the active substance or to any of the excipients, or trace residues of tetracycline. Active or suspected malignancy. Patients with a history of malignancies in the gastrointestinal tract including the hepatobiliary system within the last five years.
Special warnings and precautions for use
A colonoscopy with removal of polyps should be performed at the time of starting treatment with REVESTIVE. Once yearly follow‑up colonoscopies (or alternate imaging) are recommended during the first 2 years of REVESTIVE treatment. Subsequent colonoscopies are recommended at a minimum of five year intervals. An individual assessment whether increased frequency of surveillance is necessary should be performed based on the patient characteristics (e.g., age, underlying disease). If a polyp is found, adherence to current polyp follow‑up guidelines is recommended. In case of malignancy, REVESTIVE therapy must be discontinued.
Gastrointestinal neoplasia including hepatobiliary tract
In the rat carcinogenicity study, benign tumours were found in the small bowel and the extrahepatic bile ducts. These observations were not confirmed in clinical studies of more than one year duration. If a neoplasia is detected, it should be removed. In case of malignancy, REVESTIVE treatment must be discontinued.
Gallbladder and bile ducts
Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies. In case of gallbladder or bile duct‑related symptoms, the need for continued REVESTIVE treatment should be reassessed.
Pancreatic adverse events such as chronic and acute pancreatitis, pancreatic duct stenosis, pancreas infection and increased blood amylase and lipase have been reported in clinical studies. In case of pancreatic adverse events, the need for continued REVESTIVE treatment should be reassessed.
Monitoring of small bowel, gallbladder and bile ducts, and pancreas
SBS patients are to be kept under close surveillance according to clinical treatment guidelines. This usually includes the monitoring of small bowel function, gallbladder and bile ducts, and pancreas for signs and symptoms, and, if indicated, additional laboratory investigations and appropriate imaging techniques.
Cases of intestinal obstruction have been reported in clinical studies. In case of recurrent intestinal obstructions, the need for continued REVESTIVE treatment should be reassessed.
Fluid overload has been observed in clinical trials. Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.
Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of therapy. Patients should be advised to contact their physician in case of sudden weight gain, swollen ankles and/or dyspnoea. In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs. This assessment should be conducted more frequently within the first months of treatment.
Congestive heart failure has been observed in clinical trials. In case of a significant deterioration of the cardiovascular disease, the need for continued treatment with REVESTIVE should be reassessed.
Management of fluids during treatment with REVESTIVE
In patients receiving REVESTIVE, parenteral support should be reduced carefully and should not be discontinued abruptly. The patient’s fluid status should be evaluated following parenteral support reduction and corresponding adjustment performed, as needed.
Concomitant medicinal products
Patients receiving oral concomitant medicinal products requiring titration or with a narrow therapeutic index should be monitored closely due to potential increased absorption.
Special clinical conditions
REVESTIVE has not been studied in patients with severe, clinically unstable concomitant diseases, (e.g., cardiovascular, respiratory, renal, infectious, endocrine, hepatic, or CNS), or in patients with malignancies within the last five years. Caution should be exercised when prescribing REVESTIVE.
REVESTIVE has not been studied in patients with severe hepatic impairment. The data from use in subjects with moderate hepatic impairment do not suggest a need for restricted use.
Discontinuation of treatment
Due to the risk of dehydration, discontinuation of treatment with REVESTIVE should be managed carefully.
See also general precautions for adults under this section.
Prior to initiating treatment with REVESTIVE, faecal occult blood testing should be performed in all children and adolescents. Subsequent testing should be conducted annually while they are receiving REVESTIVE.
Prior to initiating treatment with REVESTIVE, children and adolescents 12 years of age and older should undergo a colonoscopy/sigmoidoscopy, unless one has been done within the past year. Children under 12 years of age should also have the procedure if they have unexplained blood in their stool. Colonoscopy is recommended for all children and adolescents after one year of treatment, and at least every 5 years thereafter of continuous treatment with REVESTIVE.
REVESTIVE contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially ‘sodium‑free’. Caution is needed when administering REVESTIVE to persons with a known hypersensitivity to tetracycline.
Respiratory tract infection, headache, abdominal pain and distension, vomiting, nausea, gastrointestinal stoma complication*, oedema peripheral, injection site reaction.
Influenza, decreased appetite, anxiety, sleep disorder, paraesthesia, cardiac failure congestive, flushing, dyspnoea, cough, pancreatitis, intestinal obstruction, cholestasis and cholecystitis, dermatitis allergic, rash, arthalgia, renal colic, costovertebral angle tenderness, chest pain, night sweats, C-reactive protein increased.
*Gastrointestinal stoma complication (swelling of the stoma and associated complications) is considered to be rather a sign of efficacy than an adverse reaction.
Please consult the REVESTIVE Summary Product Characteristics (SmPC) before prescribing.
For EU Summary of Product Characteristics for REVESTIVE in adults please click HERE.
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Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.
We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people’s lives with medicines that have a meaningful impact on patients and all who support them on their journey.
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, 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, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.
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