Type of information: Granting of a Market Authorisation in the EU
Product name: Revestive® (EU)/Gattex® (USA)
Compound: teduglutide (recombinant analog of human glucagon-like peptide 2)
Therapeutic area: Rare diseases
- peptide. Teduglutide is a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), a naturally occurring protein involved in the rehabilitation of the intestinal lining. It has been developed to reduce dependence on parenteral nutrition (PN) in adult patients with short bowel syndrome (SBS).
Company: NPS Pharmaceuticals (USA - NJ) now Shire (UK - USA)
Disease: short bowel syndrome
- • On May 27, 2016, Shire announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Revestive®* (teduglutide) 5 mg powder and solvent for solution for injection in paediatric patients (aged one to 17 years) with short bowel syndrome (SBS). The final decision from the European Commission is expected in August 2016.
- • On September 4, 2012, Takeda Pharmaceutical and NPS Pharmaceuticals have announced that the European Commission (EC) has granted European market authorization for teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome. The marketing authorization follows a positive opinion issued on June 21, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following the authorization, Takeda intends to provide patient access to Revestive® within Europe initially through a Named Patient Program (NPP)*.
- The marketing authorization will be held by Nycomed Danmark ApS+ and is valid in the current EU Member States. National approvals are expected in Iceland and Norway within 30 days. It is based on data obtained from the STEPS pivotal Phase 3 safety and efficacy trial, a double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition. During the study, 43 patients were randomized to a subcutaneous 0.05 mg/kg/day dose of teduglutide and 43 patients to placebo for up to 24 weeks. The proportion of patients treated with teduglutide who achieved a 20% to 100% reduction of parenteral nutrition at Week 20 and 24 was significantly higher compared with those receiving placebo, (63% versus 30%, p=0.002). Treatment with teduglutide resulted in a 4.4 litre/week reduction in parenteral nutrition requirements versus 2.3 litre/week for placebo at 24 weeks (p<0.001). Twenty-one patients treated with teduglutide (54%) versus nine on placebo (23%) achieved at least a one day reduction in parenteral nutrition administration (p=0.005). Teduglutide was well-tolerated in the doses, frequency, and duration of treatment used in this study.
• On June 21, 2012, the European Medicines Agency (EMA) has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Revestive® (teduglutide) for the treatment of adult patients with short bowel syndrome. This is the first medical treatment recommended for approval in Europe in this rare but seriously debilitating condition. Revestive® was designated as an orphan medicine in 2001.
In clinical trials, Revestive® has demonstrated that it can additionally reduce parenteral nutrition requirements in patients with short bowel syndrome.
The review by the CHMP showed that most adverse events under treatment with Revestive® were mild or moderate in severity, mainly affecting the gastrointestinal system. However, about one third of the adverse events were considered to be severe, most of them related to hepatobiliary and pancreatic events.
• On March 28, 2011, Nycomed has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for clearance to market teduglutide (Revestive®) as a once-daily subcutaneous treatment for short bowel syndrome (SBS). The submission triggers a mid-seven digit milestone payment to NPS Pharmaceuticals.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2011-03-28
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-12-21
UE authorization: 2012-09-04
Favourable opinion UE: 2012-06-21/2016-05-26
Favourable opinion USA:
Orphan status USA: 2000-06-29
Orphan status UE: 2001-11-12
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
- In 2007, NPS granted Nycomed the rights to develop and commercialize teduglutide outside the United States, Canada and Mexico. NPS retains all rights to teduglutide in these countries. The agreement provides for NPS to earn double-digit royalties on teduglutide sales in the Nycomed territories and payments related to the attainment of certain defined milestones. This agreement has been revised in 2013 and NPS has re-gained the full worldwide rights to teduglutide (trade name in Europe: Revestive®) and recombinant human parathyroid hormone 1-84 (PTH 1-84) (trade name in Europe: Preotact®).