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Short Bowel Syndrome

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Main Category: Crohn's / IBD
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 25 Jun 2012 - 12:00 PDT

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Short Bowel Syndrome (SBS) is a highly debilitating condition, which occurs when the body's gastrointestinal tract is unable to absorb sufficient nutrients and fluids due to a resection of a significant portion of the bowel as a result of Crohn's disease, ischemia or other conditions.

Because the patient's body is unable to absorb insufficient nutrients, water and electrolytes, SBS patients often suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss.

The standard treatment for SBS consists of nutritional support, such as parenteral nutrition (PN) and/or intravenous (IV) fluids to supplement and stabilize nutritional needs. PN is linked to serious complications, including infections, blood clots or liver damage. These risks increase the longer patients are on PN. Patients on PN often experience a poor quality of life with frequent urination, difficulty sleeping and loss of independence. Until now, there have been no approved therapies available in Europe to treat SBS.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has now recommended that Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc. are granted marketing authorization for teduglutide, which is known under the European trade name of RevestiveÂ®, as a once-dailyÂ treatment for adults with short bowel syndrome (SBS). The companies submitted their application for marketing authorization in March 2011 and the EMA and US FDA has now awarded Teduglutide with an orphan drug designation for the treatment of SBS.

Teduglutide (RevestiveÂ®) contains a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), i.e. a natural protein that plays a role in rehabilitating the intestinal lining and has been designed to reduce dependence on parenteral nutrition (PN) in adults with SBS. The drug has been tested in two phase III studies, with both showing a favorable safety profile and substantial reductions in the average PN volume from the start of the studies until end of treatment. Furthermore, some patients could be weaned off PN and continue a life without parenteral support.

Professor Palle Bekker Jeppesen, M.D., Ph.D, from Denmark's Copenhagen University Hospital's Department of Medical Gastroenterology explained: "Short bowel syndrome patients suffer from malnutrition and diarrhea, and often parenteral nutrition is necessary to maintain life. Revestive is a new, unique and important treatment option for our patients and is adding important value to the limited treatment armamentarium."

Trevor Smith, Head of Takeda's European and Canadian Commercial Operations said: "We welcome the positive opinion from the CHMP for teduglutide. This is good news for patients with SBS."

Francois Nader, MD, President and Chief Executive Officer of NPS Pharmaceuticals added:

"We are pleased with the Committee's recommendation, which brings us closer to our goal of making teduglutide available in Europe for patients with short bowel syndrome. Teduglutide represents an important treatment advance that could significantly reduce or even eliminate parenteral nutrition support for patients with short bowel syndrome. We congratulate our partner Takeda on receiving this positive opinion and look forward to supporting their efforts to bring this much-needed therapy to patients."

The CHMP based their decision to recommend teduglutide on two trials. The first pivotal phaseÂ 3 double-blind, placebo-controlled study involved a total of 86 SBS patients in need of parenteral nutrition, of which 43 patients were randomized to a subcutaneous 0.05 mg/kg/day dose of teduglutide whilst the remaining 43Â patients were given placebo for up to 24Â weeks.

The findings revealed that those in the teduglutide group achieved reductions between 20% to 100% of parenteral nutrition at WeekÂ 20 and 24, which was statistically substantially different compared with those in the placebo group, i.e. 63% compared with 30%, p=0.002. At 24Â weeks, patients in the teduglutide group had a 4.4Â l/week reduction in parenteral nutrition requirements compared with 2.3Â l/week for placebo (p

The second phaseÂ 3 double blind, placebo-controlled study involved 83 SBS patients who required parenteral nutrition, of which 35 patients received a 0.05Â mg/kg/day dose of teduglutide subcutaneously, whilst 32 patients received a 0.10Â mg/kg/day dose of teduglutide and 16 patients placebo for a duration of up to 24Â weeks.

The study's primary efficacy evaluation demonstrated no statistically important differences between the teduglutide 0.10Â mg/kg/day group and the placebo group. However, the number of participants (46%) administered with the recommended dose of teduglutide of 0.05Â mg/kg/day at WeekÂ 20 andÂ 24 reported a reduction of at least 20% in parenteral nutrition, which proved statistically important with regard to those (6%) in the placebo group. At week 24, the researchers noted that in comparison with placebo, teduglutide resulted in a 2.5Â l/week decrease in parenteral nutrition requirements, whilst those on placebo only achieved 0.9Â l/week (p=0.08). Furthermore, they observed that the 0.05 mg/kg daily dose of teduglutide was well tolerated during the study duration.Â

In 2007, NPS Pharmaceuticals Inc., which has all rights to teduglutide in North America, granted Nycomed the rights to develop and commercialize teduglutide outside the U.S., Canada, Mexico and Israel. In November 2011, the US FDA received a new drug application for teduglutide from NPS, which is known in the US under the trade name GattexÂ®.

Written by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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Senin, 25 Juni 2012

Short Bowel Syndrome

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