e removed during the procedure. A patient registry could gather long-term responses to the drug and, like most REMS programmes, physicians would need to complete an education program on risks. And the company proposes to help manage risk with a direct patient support programme [25].
13/10/2012 17:15:42
Sep 12: Marketing authorisation approved in the EU [24].
04/09/2012 21:23:32
Aug 12: Application will be discussed at the FDA´s Gastrointestinal Drugs Advisory Committee meeting scheduled for Oct 16, 2012 [23].
28/08/2012 09:00:40
Aug 12: FDA decision date delayed to 30 Dec 12 [22].
13/08/2012 16:45:58
Jun 12: EU positive opinion [21].
22/06/2012 16:02:25
May 12: FDA decision expected by 28 Sep [20].
16/05/2012 17:42:29
Jan 12: FDA has accepted and filed for review [19].
01/02/2012 15:17:52
Dec 11: Company has completed the submission of a New Drug Application (NDA) to the FDA and has asked for a priority review [18].
01/12/2011 21:58:54
Aug 11: Company has started a rolling submission of evidence to support the NDA in the US [16]
19/08/2011 12:43:48
March 11: Marketing Authorisation Application submitted to the EMA for approval of teduglutide as a once-daily subcutaneous treatment for short bowel syndrome (SBS). [14]
29/03/2011 10:19:11
Jan 11: Filing planned for 1H 2011 in EU and 2H 2011 in US [13].
31/01/2011 19:30:03
The US FDA recommended that the company should conduct a confirmatory PIII trial of teduglutide for SBS prior to the submission of a NDA for the drug. The STEPS trial is now underway (8).
24/03/2009 16:22:43
Orphan drug status in EU since Dec 01 (6)
11/04/2008 13:00:57
PIII in US with orphan drug status. Pivotal PIII study started in pts with short bowel syndrome (1).
Trial or other data
Oct 13: New findings from STEPS 2, two-year open-label study: Investigators report long-term use of Gattex in pts with SBS resulted in additional, clinically meaningful reductions in the volume and days per week of parenteral support requirements in this extension study. In addition, 10 of the 13 pts who achieved complete independence from parenteral support were those who received 30 months of Gattex in the 6-month STEPS pivotal study and the 24-month STEPS 2 study. Two pts who received placebo in STEPS and 24 months of Gattex in STEPS 2 and one pt who bypassed STEPS and was enrolled directly into STEPS 2 also achieved independence from parenteral support. [3]
16/10/2013 15:50:26
Nov 11: In the STEPS 2 study, there were three cases of cancer, two of which resulted in death, reported at two sites in Poland. These cases have been reviewed by a safety review board & no changes in study design or current monitoring of subjects in the trial have been requested [17].
02/11/2011 10:15:32
Oct 11: Data from long-term, open-label STEPS 2 study. Teduglutide was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition and IV fluid volume in adult subjects with short bowel syndrome. Primary study objective was to assess long-term safety and durability of effect in 76 subjects who completed, participated in, or qualified for participation in STEPS. 91% responded after 12 months of teduglutide, i.e. had a 20-100% reduction in PN/IV volume from baseline. 24% of subjects reduced their infusion days per week by 3 or more days after 12 months of therapy. Three subjects participating in STEPS 2 we |
