EU approved Revestive a month ago:
>>OSAKA, Japan & BEDMINSTER, N.J.--(BUSINESS WIRE)--Sep. 4, 2012-- Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda") and NPS Pharmaceuticals, Inc. (NASDAQ: NPSP, "NPS"), jointly announced today that the European Commission (EC) has granted European market authorization for the medicinal product 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)*. "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., Ph.D, Department of Medical Gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark. "Revestive is a new, unique and important treatment option for our patients and is adding important value to the limited treatment armamentarium."
"Teduglutide is the first approved treatment in Europe for this debilitating disease and offers an important new treatment option to patients who are reliant on parenteral nutrition," said Trevor Smith, Head of Commercial Operations, Europe & Canada, of Takeda.
"The granting of European marketing authorization for teduglutide is welcome news for patients who suffer from short bowel syndrome," said Francois Nader, MD, President and Chief Executive Officer of NPS Pharmaceuticals. "We look forward to supporting our partner Takeda as it works to launch this important therapy for patients in Europe."
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.1
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.1
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) and/or intravenous (IV) fluids 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.
About Teduglutide (Revestive®)
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). Two Phase 3 studies 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.1,2
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 biopharmaceutical 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 and Israel. NPS retains all rights to teduglutide in North America. NPS submitted a new drug application for teduglutide to the U.S. Food and Drug Administration (FDA) in November 2011. Teduglutide is known as Gattex® in the U.S.<<
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NDA filed last November, so any time now here. Th rhPTH biologic -- Natpara -- BLA is moved to middle of next year after FDA requested a change in the instructions for injecting it. This sounds like a "crossing of Tees" type request -- no further trials or other information was requested -- but the delay is annoying. I suppose I should listen to a CC to hear about launch plans for Revestive/Gattex beyond the NPP. Will that be the strategy in the U.S., too?
Cheers, Tuck |
