Once the clinical trials for a potential drug are completed, all of the data related to safety and efficacy are compiled into a registration dossier that is submitted to regulatory authorities. Evaluation of this dossier, which comprises hundreds of thousands of pages, includes extensive follow-up questions from regulatory authorities.
Alendronate effervescent EX101
Teduglutide (Revestive®)
Ciclesonide HFA nasal
| Project |
Alendronate effervescent EX101 is a patient-friendly formulation that dissolves in water. Alendronate is a bisphosphonate for the treatment of osteoporosis.
EffRx and Nycomed announced on 29 September that the first European filing for marketing approval of EX101, the once-a-week 70mg buffered effervescent alendronate, has been submitted. |
| Medical need |
This compound will strengthen Nycomed’s existing portfolio in osteoporosis, a disease which affects at least 200 million people and is expected to increase dramatically as the global population ages. |
| Therapeutic area |
Osteoporosis |
| Partner |
EffRx
Nycomed received the exclusive rights to develop, manufacture and commercialise EX101 for the treatment of osteoporosis in a large number of countries worldwide. |
| News |
21.09.10 First European Filing for Marketing Approval of Osteoporosis Drug
14.01.09 Nycomed strengthens its osteoporosis portfolio |
| Project |
Teduglutide is an analogue of human glucagon-like peptide (GLP-2), a naturally occurring hormone. It has potential to encourage the growth of the cells lining the gastrointestinal tract. This could give patients with Short Bowel Syndrome (SBS) the hope to reduce their need for parenteral nutrition.
Teduglutide has received orphan drug designation from both EMA and FDA.
Marketing Authorisation Application was submitted for EU in March 2011. |
| Medical need |
Short bowel syndrome (SBS) is a rare malabsorption disorder, with an estimated 10,000 sufferers in Europe. SBS is caused by the surgical removal of 50% or more of the small intestine, which impairs intestinal function and food absorption and often requires intravenous feeding. |
| Therapeutic area |
Gastroenterology / short bowel syndrome |
| Partner |
NPS Pharmaceuticals
Nycomed obtained the exclusive rights to develop and commercialise teduglutide outside the United States, Canada and Mexico for the treatment of gastrointestinal disorders. |
| News |
28.03.2011 Nycomed submits European MAA for teduglutide (Revestive®) |