Nycomed submits European MAA for teduglutide (Revestive®)

28.03.2011
  • Marketing Authorisation Application submitted for EU
  • Treatment aimed at patients with Short Bowel Syndrome (SBS), a rare and highly disabling condition that impacts patients’ quality of life and can lead to serious life-threatening complications
  • Teduglutide (Revestive®) has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)

Nycomed has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency for teduglutide (Revestive®) as a once-daily subcutaneous treatment for Short Bowel Syndrome (SBS). Teduglutide is a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), a protein involved in the rehabilitation of the intestinal lining. Revestive® has received orphan drug designation as SBS is a rare disease affecting less than 10,000 patients in Europe.

Short Bowel Syndrome (SBS) is a rare disease characterized by a severely impaired ability to absorb nutrients and fluids in people who have had a significant portion of their small intestine removed. SBS typically arises after surgical removal of the bowel due to Crohn’s disease, ischemia or other conditions.

Nycomed’s submitted MAA is based on a randomised, placebo-controlled study in SBS patients from Europe, Canada and the US. The study demonstrated that teduglutide (Revestive®) 0.05 mg/kg bodyweight was effective in reducing the need for parenteral support by at least 20% (46% of teduglutide-treated patients responded versus 6% of placebo-treated patients). Further reductions in parenteral support were seen in a six month follow-up study. Three teduglutide-treated patients were able to be weaned off parenteral support.

Anders Ullman, Executive Vice President R&D of Nycomed, said: “This submission clearly demonstrates Nycomed’s dedicated efforts and strong commitment to bring new and innovative treatments to patients and caregivers addressing a high unmet medical need.”

“Short Bowel Syndrome patients suffer from malnutrition and diarrhoea, and often parenteral nutrition is necessary to maintain life,” said Professor Palle Bekker Jeppesen, M.D., Department of Medical Gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark. “The clinical data suggest that teduglutide helps to improve intestinal function in SBS patients, thereby reducing dependence on parenteral nutrition, giving them better fluid and energy absorption and potentially improving their quality of life. The addition of teduglutide to the limited treatment armamentarium may increase the awareness of this debilitating condition and its submission brings us closer to an important new therapeutic option for our patients.”

About Short Bowel Syndrome

Short bowel syndrome (SBS) is a highly disabling condition that can impair a patient's quality of life and lead to serious life-threatening complications. SBS typically arises after extensive resection of the bowel due to Crohn’s disease, ischemia or other conditions. SBS patients often suffer from malnutrition, severe diarrhoea, dehydration, fatigue, osteopenia, and weight loss due to the reduced intestinal capacity to absorb nutrients, water, and electrolytes. The usual treatment for short bowel syndrome is nutritional support, including parenteral nutrition (PN) to supplement and stabilize nutritional needs.

Although PN can provide nutritional support for short bowel syndrome patients, it does not improve the body’s own ability to absorb nutrients. PN is also associated with serious complications, such as infections, blood clots or liver damage, and the risks increase the longer patients are on PN. Patients on PN often experience a poor quality of life with difficulty sleeping, frequent urination and loss of independence.

In Europe, the estimated prevalence of approximately four SBS patients per million inhabitants makes it a rare but very debilitating disease.

About Teduglutide (Revestive®)

Teduglutide is a novel, recombinant analogue of human glucagon-like peptide 2, a 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). A phase III study of teduglutide demonstrated a favorable safety profile and significant reductions in mean PN volume from baseline to end of treatment. In addition some patients were able to be weaned off PN and continue their life without parenteral support

Teduglutide has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).

In 2007, NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, granted Nycomed the rights to develop and commercialize teduglutide outside the United States, Canada and Mexico. NPS retains all rights to teduglutide in North America.

About Nycomed

Nycomed is a privately owned global pharmaceutical company with a diversified portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. A range of OTC products completes the portfolio.

Its R&D is structured around collaborations. In-licensing and expanding in emerging markets are cornerstones of the company's growth strategy.

Nycomed employs 12,500 associates worldwide, and its products are sold in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS, Latin America, Asia and the Middle East. In the US and Japan its products are available through best in class partners.

Headquartered in Zurich, Switzerland, the company generated total sales of € 3.2 billion in 2010 and an adjusted EBITDA of € 851 million.

 

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