New drug for short bowel syndrome! Shire's Gattex (Tydioglutide) treatment of paediatric adaptive disorders has entered the formal U.S.:

British pharmaceutical company Shire recently announced that the U.S. Food and Drug Administration (FDA) has accepted Gattex (teduglutide) supplementary new drug application (sNDA). The sNDA applied for approval to expand the adaptation of Gattex injections for the treatment of pediatric patients (1-17 years of age) who rely on intestinal support for short bowel syndrome (SBS). The FDA is expected to make a review decision in March 2019. Gattex is a prescription drug that has previously been approved by the FDA for adult patients who rely on intestinal support for SBS.
SBS is a severe, chronic and rare disorder of absorption caused by surgical excision. SBS patients are unable to absorb enough nutrients and fluids from their diet. Poor absorption can lead to diarrhea, dehydration, electrolyte disorders and malnutrition in such patients. In addition to serious complications, the social life of SBS patients can be severely restricted. SBS children who have had most of their small intestines surgically removed due to congenital or congenital diseases in newborns need long-term infusions of extraintestinal/intravenous (PN/IV).
Shire's chief medical officer, Howard Mayer, said the FDA's acceptance of Gattex SNDA was an important milestone in the company's assessment of Gattex as a potential treatment option for SBS pediatric patients who rely on intestinal support. Addressing medical needs in the area of rare diseases is a priority for Shire, and we are pleased to continue to advance the development of gastrointestinal portfolios to help groups of patients with rare and special gastrointestinal diseases.
data included in
SNDA include data from 2 core, completed Phase III clinical studies (TED-C14-006 and TED-C13-003), as well as interim data from 2 ongoing extended studies.
U.S. market, Gattex was approved at the end of 2012, making it the first major advance in SBS's long-term treatment in nearly 40 years. The drug's unique mechanism of action enhances the absorption of the gastrointestinal tract. In clinical studies, the volume of infusions required by patients with extraintestinal/intravenous (PN/IV) infusions and the number of days of infusion per week were significantly lower than the baseline, and some patients were even able to get rid of PN/IV support. (Bio Valley)
original source: U.S. FDA Accepts for Filing Shire’s Supplemental New Drug Application for GATTEX® (teduglutide [rDNA origin]) for Children with Short Bowel Syndrome