Healthcare Industry News: S.A.
News Release - May 17, 2019
U.S. FDA Approves GATTEX(R) (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)
GATTEX is the only glucagon-like peptide-2 (GLP-2) analog approved that improves intestinal absorption in patients with SBS who are dependent on parenteral support (PS)¹GATTEX has been shown to reduce PS volume and to help some children with SBS wean off of intravenous nutrition over time during clinical studies¹
LEXINGTON, Mass., May 17, 2019 -- (Healthcare Sales & Marketing Network) -- Takeda Pharmaceuticals, U.S.A., Inc. ("Takeda"), announced today that the U.S. Food and Drug Administration (FDA) approved extending the indication of GATTEX® (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).1
In children, SBS iS.A.life-threatening, chronic, and rare malabsorption disorder resulting from surgical removal of a large portion of the intestine, which is typically due to congenital or acquired conditions of the newborn or trauma.2-4 Children with SBS.A.e unable to absorb enough nutrientS.A.d fluids from what they eat and drink alone.2 A goal of SBS treatment is to restore the remaining intestine'S.A.ility to absorb nutrientS.A.d reduce long-term dependence on parenteral support (PS).2
"AS.A.pediatric gastroenterologist, one of my main treatment goals for children with SBS is to reduce their dependency on parenteral support," said Beth Carter, MD, Medical Director of Intestinal Rehabilitation and Nutrition Support, Children's Hospital LoS.A.geles. "I'm pleased that patients have access to a medication that may help them reach that goal."
GATTEX is the first and only medicine that mimics naturally occurring glucagon-like peptide-2 (GLP-2), which helps the remaining intestine absorb more nutrients.1 In a pharmacodynamic study in adults, GATTEX was shown to improve the amount of fluidS.A.sorbed by the intestines.1
"Addressing high unmet needs of patients with complex and debilitating gastrointestinal (GI) conditions iS.A.focus of Takeda's work," said Andrew Grimm, Global Clinical Development Lead, Takeda. "As the first U.S.-approved therapy in pediatric SBS patients dependent on PS that improveS.A.sorption, GATTEX offers these patients new hope to reduce PS requirementS.A.d the potential for PS independence. ThiS.A.proval underscores Takeda's commitment to patients with rare and devaS.A.ing GI conditions like SBS."
In a 24-week pediatric study, GATTEX helped reduce the volume of daily PS required and time spent administering PS. Some children even achieved complete freedom from PS.1 Fifty- nine pediatric patients with SBS.A.ed 1 year through 17 years chose whether to receive GATTEX or S.A.dard of care (SOC). Patients who chose to receive GATTEX treatment were subsequently randomized in a double-blind manner to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 patients enrolled in the SOC arm. The recommended dosage of GATTEX is 0.05 mg/kg/day. Randomization to the GATTEX dose groups was stratified by age.1
At the end of the 24-week study, 69% of patients (18/26) who took GATTEX 0.05 mg/kg each day reduced PS volume by 20% or more. Based on patient-diary data, patients who received GATTEX 0.05 mg/kg/day experienced a 42% mean reduction in PS volume (mL/kg/day) from baseline (-23 mL/kg/day from baseline). At week 24, 38% of patients (10/26) were able to reduce PS infusion by at least 1 day per week.1 Patients reduced their PS infusion time by 3 hours per day on average compared to baseline.5 In addition, during this study 3 out of 26 (12%) children who received GATTEX 0.05 mg/kg/day completely weaned off PS.1
GATTEX haS.A.demonstrated safety profile that is similar overall in pediatric and adult patients. The most common adverse reactions (≥10%) seen in adult patients treated with GATTEX in clinical trials were abdominal pain, nauS.A. upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.1
About Pediatric Short Bowel Syndrome (SBS)
Malabsorption of fluidS.A.d nutrients can place children with SBS.A. risk for diarrhea, dehydration, electrolyte disturbances, and malnutrition.6 ParentS.A.d caregivers of children with SBS who are dependent on PS have reported in studies that they experience deterioration in their family life, social life, and work.4,7 PS reductions may represent a benefit to the lives of children with SBS, potentially giving them the freedom to do daily-life activities.8,9
About GATTEX® (teduglutide) for Injection
GATTEX® (teduglutide) iS.A.recombinant analog of human glucagon-like peptide-2. In the U.S., GATTEX is indicated for the treatment of adultS.A.d pediatric patients 1 year of age and older with Short Bowel Syndrome who are dependent on parenteral support. The recommended dosage of GATTEX for both adultS.A.d pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. Use of the GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 10 kg. The recommended dosage in adult and pediatric patients with moderate to severe renal impairment and end-S.A.e renal diS.A.e (estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2) is 0.025 mg/kg once daily.1
For more information, visit www.gattex.com.
IMPORTANT SAFETY INFORMATION
WarningS.A.d Precautions
Acceleration of Neoplastic growth
Colorectal polyps were identified during clinical trials. There iS.A.risk for acceleration of neoplastic growth. In adults, within 6 months prior to S.A.ting treatment with GATTEX, colonoscopy of the entire colon with removal of polyps should be performed and follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies should be performed every 5 years or more often as needed.
In children and adolescents, perform fecal occult blood testing prior to initiating treatment with GATTEX. Colonoscopy/sigmoidoscopy is required if there is unexplained blood in the stool. Perform subsequent fecal occult blood testing annually in children and adolescents while they are receiving GATTEX. Colonoscopy/sigmoidoscopy is recommended for all children and adolescentS.A.ter 1 year of treatment, every 5 years thereafter while on continuous treatment with GATTEX, and if they have new or unexplained gastrointestinal bleeding.
In case of intestinal malignancy (GI tract, hepatobiliary, pancreatic), discontinue GATTEX. The clinical decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit-risk considerations.
Intestinal obstruction
Intestinal obstruction has been reported in clinical trialS.A.d postmarketing. In patients who develop intestinal or stomal obstruction, GATTEX should be temporarily discontinued pending further clinical evaluation and management.
Biliary and pancreatic diS.A.e
Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported in clinical trialS.A.d postmarketing. Laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) should be obtained within 6 months prior to S.A.ting GATTEX. Subsequent laboratory tests should be done every 6 months or more often as needed. If clinically meaningful changeS.A.e seen, further evaluation is recommended including imaging, and continued treatment with GATTEX should be reassessed.
Fluid imbalance and fluid overload
Fluid overload and congestive heart failure have been observed in clinical trials. If fluid overload occurs, especially in patients with underlying cardiovascular diS.A.e, parenteral support should be adjusted and GATTEX treatment reassessed. If significant cardiac deterioration develops while on GATTEX, continued GATTEX treatment should be reassessed.
Discontinuation of treatment with GATTEX may also result in fluid and electrolyte imbalance. Fluid and electrolyte S.A.us should be monitored in patients who discontinue treatment with GATTEX.
Increased absorption of concomitant oral medication
In clinical trials, one patient receiving prazepam concomitantly with GATTEX experienced dramatic deterioration in mental S.A.us progressing to coma during first week of GATTEX therapy. Patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index should be monitored for adverse reactions due to potential increased absorption of the concomitant drug. The concomitant drug may require a reduction in dosage.
Adverse Reactions
The most common adverse reactions (≥ 10%) with GATTEX are abdominal pain, nauS.A. upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.
Use in Specific Populations
Breastfeeding is not recommended during treatment with GATTEX.
Please see the full Prescribing Information at: www.shirecontent.com/PI/PDFS/Gattex_USA_ENG.pdf.
Takeda's Commitment to Gastroenterology
Gastrointestinal (GI) diS.A.es can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicineS.A.d dedicated patient diS.A.e support programs for over 25 years. Takeda aspires to advance how patients manage their diS.A.e. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel diS.A.e, acid-related diS.A.eS.A.d motility disorders. Our GI ReS.A.ch & Development team iS.A.so exploring solutions in celiac diS.A.e and liver diS.A.es, as well as scientific advancements through microbiome therapies.
About Takeda in the United S.A.es
Takeda has maintained a strong and growing commitment to the United S.A.es for more than 50 years. On January 8, 2019, Takeda completed itS.A.quisition of Shire, PLC, becoming a global, values-based, R&D-driven biopharmaceutical leader. In the U.S., Takeda employs more than 18,000 employeeS.A.ross multiple business units, and as of August 2019, will be headquartered out of the greater Boston area.
Additionally, Takeda also haS.A.reS.A.ch facility in San Diego, California, specialty products manufacturing facilities in Brooklyn Park, Minnesota and plaS.A.fractionation manufacturing facilities in Covington, Georgia.
As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in tranS.A.ing science into life-changing medicines to the next level, in our core focuS.A.eas; oncology, gastroenterology, neuroscience, rare diS.A.es, plaS.A.derived therapies, and vaccines.
References:
1 GATTEX (teduglutide) for injection [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc; 2019.
2 Chandra R, Kesavan A. Current treatment paradigms in pediatric short bowel syndrome. Clin J Gastroenterol. 2018;11(2):103-112.
3 Wales PW, De Silva N, Kim J, Lecce L, To T, Moore A.. Neonatal short bowel syndrome: population- based estimates of incidence and mortality rates. Semin Pediatr Surg. 2004;39(5):690-695.
doi:10.1053/j.sempedsurg.2009.11.001.
4 Pederiva F, Khalil B, Morabito A, Wood SJ. Impact of short bowel syndrome on quality of life: the patient's perspective. Eur J Pediatr Surg. 2017. doi:10.1055/s-0037-1621737.
5 Study NCT02682381. Available at clinicaltrials.gov/ct2/show/study/NCT02682381 (accessed May 6, 2019).
6 Thompson JS, Weseman R, Rochling FA, Mercer DF. Current management of the short bowel syndrome. Surg Clin N Am. 2011;91:493-510. doi: 0.1016/j.suc.2011.02.006
7 Jeppesen PB, Langholz E, Mortensen PB. Quality of life in patients receiving home parenteral nutrition. Gut. 1999;44:844-852.
8 Emedo MJ, Godfrey EI, Hill SM. A qualitative study of the quality of life of children receiving intravenous nutrition at home. J Ped Gastroenterol Nutr. 2010;50(4):431-440.
9 O'Keefe SJD, Jeppesen PG, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013;11(7):815-823.
Source: Takeda Pharmaceuticals
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