XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
 Psychiatry
 Genetics
 Surgery
 Aging
 Ophthalmology
 Gynaecology
 Neurosciences
 Pharmacology
  Anti-Inflammatory
  Antivirals
  Antihypertensives
  Anticholesterol
  Anti-Clotting Drugs
  Anti Cancer Drugs
  Hypnotics
  PPI
  Antibiotics
  Analgesics
  Surfactants
  Fatty Acids
  Adrenergics
  Metals
  Varenicline
 Cardiology
 Obstetrics
 Infectious Diseases
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
Search

Last Updated: Nov 17th, 2006 - 22:35:04

Pharmacology Channel
subscribe to Pharmacology newsletter

Latest Research : Pharmacology

   DISCUSS   |   EMAIL   |   PRINT
Mecasermin rinfabate Granted Priority Review Status for the Treatment of Growth Hormone Insensitivity Syndrome
Apr 14, 2005, 20:49, Reviewed by: Dr.

Insmed's SomatoKine(R) is a proprietary delivery composition of insulin-like growth factor-I (IGF-I) and its principal binding protein, IGFBP-3. The novel compound is administered as a single daily subcutaneous injection, which can restore IGF levels into the normal range.

 
Insmed Incorporated (NASDAQ: INSM) announced today that the Company has received Priority Review notification from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for its drug candidate SomatoKine (mecasermin rinfabate). The FDA has notified the Company that the User Fee Goal Date is July 3, 2005.


The FDA previously granted SomatoKine, an IGF-I therapy, orphan drug designation, a designation conferred upon investigational products for diseases that affect fewer than 200,000 patients in the United States. Products with orphan drug designation that are the first to be approved for a specific indication have seven years market exclusivity within the United States.

More on SomatoKine(R)

Insmed's SomatoKine(R) is a proprietary delivery composition of insulin-like growth factor-I (IGF-I) and its principal binding protein, IGFBP-3.

The novel compound is administered as a single daily subcutaneous injection, which can restore IGF levels into the normal range.

On March 10 Insmed announced that the FDA had accepted Insmed's NDA submission for SomatoKine(R) for the treatment of Growth Hormone Insensitivity Syndrome (GHIS). Previously, Insmed provided the results from a six-month data analysis of the ongoing pivotal Phase III GHIS clinical trial showing a statistically significant increase (p less than 0.0001) in height velocity in children receiving SomatoKine(R) as a once-daily injection. In diabetic subjects, administration of SomatoKine(R) demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. Following severe burn injury, in both children and adults, administration of SomatoKine(R) demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In recovery from hip fractures, administration of SomatoKine(R) has demonstrated a significant improvement in functional recovery and bone mineral density.
 

- U.S. Food and Drug Administration (FDA)
 

www.insmed.com

 
Subscribe to Pharmacology Newsletter
E-mail Address:

 

Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com .

Statements included within this press release that are not historical in nature may constitute forward-looking statements for purposes of the safe harbour provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding clinical trials and goals, our regulatory and business strategies and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.

Contacts
Insmed Incorporated
Baxter Phillips, III, 804-565-3041
Fax: 804-565-3510
[email protected]


Related Pharmacology News

Phase Ib Trial Is Evaluating Bavituximab Administered With Common Chemotherapy Regimens
Two-component lantibiotic with therapeutic potential discovered
Prescription pain medication abuse on rise
Antibiotic inhibits cancer gene activity
NRTIs limits the atherogenic side effect of the protease inhibitors
Cyclin-dependent kinase inhibitors: The latest anti-inflammatory
FDA requested to promptly approve 17-P to prevent premature birth
Rapamycin shown to inhibit angiogenesis
Tigecycline, world�s first glycylcycline expanded broad-spectrum antibiotic, launched in UK
Ibuprofen - worsening cognitive function


For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us