Takeda Announces FDA Approval of Dexilant (dexlansoprazole) for Patients 12-17 Years of Age

July 11, 2016

Dexilant has been approved in adult patients since 2009

Deerfield, Ill., July 11, 2016 – Takeda Pharmaceuticals U.S.A., Inc., (Takeda) (TSE: 4502) today announced that the United States (U.S.) Food and Drug Administration (FDA) approved Dexilant delayed-release capsules and Dexilant SoluTab delayed-release orally disintegrated tablets for patients ages 12-17 years old with gastroesophageal reflux disease (GERD). Dexilant is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed EE and relief of heartburn. Dexilant capsules are approved for the healing of erosive esophagitis (EE).

“Takeda is pleased with the FDA’s approval to expand the access of Dexilant to younger patients with GERD,” explained Thomas Gibbs, Senior Vice President, General Medicines, Takeda. “This new approval provides an alternative treatment option for appropriate patients with this condition. With our more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions.” 

Since being approved by the FDA, Dexilant capsules have been available for nearly 7 years with over 28 million prescriptions filled. Takeda’s Help At Hand provides assistance for people who have no insurance or who do not have enough insurance and need help getting their Takeda medicines. All applications are reviewed on a case-by-case basis in accordance with program criteria.

About GERD
GERD is a chronic condition commonly known as acid reflux disease. GERD can occur when the valve at the lower end of the esophagus, called the lower esophageal sphincter (LES), does not work properly. This valve opens to allow food and liquids to enter the stomach and closes to keep acid and food in the stomach. When the LES does not close as tightly as it should, or relaxes too often, it can cause stomach contents to get into the esophagus. 

GERD affects about 20 percent of the U.S. population and is often characterized by frequent and persistent heartburn two or more days a week despite treatment and diet changes. 

INDICATIONS
DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules are indicated in patients 12 years of age and older for:

  • Healing all grades of erosive esophagitis (EE) for up to 8 weeks
  • Maintaining healing of EE and relief of heartburn for up to 6 months in adults and 16 weeks in patients 12 to 17 years of age
  • Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks


DEXILANT SoluTab (dexlansoprazole) 30 mg delayed-release orally disintegrating tablets are indicated in patients 12 years of age and older for:

  • Maintaining healing of EE and relief of heartburn for up to 6 months in adults and 16 weeks in patients 12 to 17 years of age
  • Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks


Use of DEXILANT in patients 12 to 17 years of age is supported by evidence from adequate and well-controlled studies of DEXILANT capsules in adults with additional safety, efficacy and pharmacokinetic data in pediatric patients 12 to 17 years of age. The safety and effectiveness of DEXILANT have not been established in pediatric patients less than 12 years of age.

IMPORTANT SAFETY INFORMATION

  • DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis, have been reported. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole. PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products.
  • In adults, symptomatic response to therapy with DEXILANT does not preclude the presence of gastric malignancy.
  • Acute interstitial nephritis has been observed in patients taking PPIs, including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops.
  • Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (Vitamin B-12).
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
  • Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated.
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
  • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity which may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop DEXILANT treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.
  • Concomitant use of PPIs with methotrexate may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of DEXILANT.
  • Most commonly reported adverse reactions in adults taking Dexilant were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). The adverse reaction profile in patients 12 to 17 years of age was similar to adults taking DEXILANT. The most commonly reported adverse reactions in patients 12 to 17 years of age (≥ 5%) were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with DEXILANT may reduce antiviral effect. Avoid concomitant use of nelfinavir with DEXILANT. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with DEXILANT may increase toxicity of the antiretroviral drugs.
  • Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
  • DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., drugs with pH-dependent absorption such as digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil [MMF], ketoconazole/itraconazole). Use DEXILANT with caution in transplant patients receiving MMF.
  • Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.
  • A hyper-response in gastrin secretion in response to the secretin stimulation test may falsely suggest gastrinoma. Temporarily stop DEXILANT treatment at least 30 days before assessing to allow gastrin levels to return to baseline.
  • There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
  • Avoid concomitant use of DEXILANT with St. John’s Wort or rifampin due to decreased exposure of DEXILANT.
  • No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C). The use of DEXILANT is not recommended for these patients.


Please see accompanying full Prescribing Information, including Medication Guide for DEXILANT.

About Takeda Pharmaceuticals U.S.A., Inc.
Headquartered in Deerfield, IL as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE: 4502), Osaka, Japan, the Company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of R&D focus include central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website,www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

Contacts:

Roseanne Durril
Takeda Pharmaceuticals U.S.A., Inc.
224-554-1474
roseanne.durril@takeda.com