Scroll Up
Scroll Down
Play Play Play Play
Unregistered User
Click here if this is not your Personal Edition
 
Contact Us | Free E-Mail Updates | Journals | Register a colleague
 
 
Endocrinology Other
 
   
 
SEARCH   
Doctor's Guide Free CME
Medline
Congress Resource Centre
 

 EXPLORE :
   Most Read News
 All News  All News
 All Webcasts / CME  All Webcasts / CME
 All Cases  All Cases
 Congress Resource Centre  Congress Resource Centre
 All Medical Resources  All Medical Resources
 Medical  My Personal Edition



Warning | Privacy

 

 
 Recent news - Endocrinology Other
    Study Shows Monitoring Bone Density in Older Women Unnecessary, Potentially Misleading - (DGNews)
    Children With Subclinical Hypothyroidism Do Not Experience Increase in Height With Thyroxine Therapy: Presented at ENDO 09 - (DGDispatch)
    Testosterone Therapy Improves Metabolic Syndrome, Liver Steatosis in Hypogonadal Men: Presented at ENDO 09 - (DGDispatch)
    Complement Component 3 Linked to Metabolic Syndrome in Patients Receiving Statins: Presented at ENDO 09 - (DGDispatch)
    Isolated Familial Hypogonadotropic Hypogonadism and a GNRH1 Mutation - (N Engl J Med)

    News archive

     Recent webcasts/CME - Endocrinology Other
    • Matching Treatment to Need in Type 2 Diabetes: Using Incretin-Based Oral Therapies Across the Clinical Spectrum
    • Achieving Glycemic Control After Standard Therapy Has Failed
    • Management of New Diabetes Case With Compromised Renal Function
    • Luteal Support in Reproduction
      Diagnosis of the Syndrome of Inappropriate Secretion of Antidiuretic Hormone

      Webcasts/CME archive

       Recent cases - Endocrinology Other
        Food-Dependent Cushing's Syndrome
        Parathyroid Apoplexy, the Explanation of Spontaneous Remission of Primary Hyperparathyroidism: A Case Report
        Deficiency of Growth Hormone in an Adult Man Case of Idiopathic Adrenocorticotropin Deficiency
        Polycystic Ovary Syndrome and Prolactinoma Association
        Improvement of the Diabetic Foot Upon Testosterone Administration to Hypogonadal Men with Peripheral Arterial Disease. Report of Three Cases

        Cases archive
          




        my personal edition > endocrinology other > news
        divider

          E-Mail this DGNews to a colleague

        DGNews


        FDA Approves Insmed's Orphan Drug, Iplex (mecasermin rinfabate [rDNA origin] injection), for Treatment of Severe Primary IGF-1 Deficiency

        The First Once-Daily Therapy for the Treatment of Severe Primary IFG-1 Deficiency

        RICHMOND, VA -- December 13, 2005 -- Insmed Incorporated announced the United States Food and Drug Administration (FDA) approved Iplex(TM) (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. As an orphan drug, Iplex is entitled to seven years of marketing exclusivity for the treatment of Primary IGFD.

        "We are very pleased Iplex was approved, making Iplex the only approved once-daily IGF-1 replacement therapy available to treat children with severe short stature," stated Geoffrey Allan, PhD, President and Chief Executive Officer of Insmed. "Today marks the beginning of a new treatment paradigm for treating children with Primary IGFD. I am grateful to all who have made this drug approval possible. This is also an exciting transition for Insmed as we now begin to focus on the commercialization of Iplex, which we expect to launch during the second quarter of calendar year 2006."

        Andreas Sommer, PhD, Chief Scientific Officer of Insmed added, "This event marks the end of a long road and two decades of hard work by hundreds of dedicated people. I'm thrilled that our visionary efforts have now culminated in making available a novel therapeutic composition for the treatment of children who suffer from Primary IGFD."

        "It is gratifying to see that a Company who cares for the needs of patients has developed a needed therapy that allows physicians to treat children with Primary IGFD. From my experience in treating these types of patients, Iplex therapy has produced improvements in growth rates while providing an excellent safety profile" said Louis Underwood, M.D., Professor of Pediatrics, University of North Carolina, Chapel Hill, and a Principal Investigator and a member of Insmed's Pivotal Trial Steering Committee. Dr. Underwood is a world renowned Pediatric Endocrinologist who pioneered the early use of GH and IGF-1.

        More on Iplex
        Iplex, mecasermin rinfabate, is the human recombinant of the naturally occurring protein complex of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). The targeted treatment indication for Iplex is Primary IGFD which encompasses a variety of genetic and acquired conditions in which the action of growth hormone (GH) is absent or attenuated resulting in low serum levels of IGF-I.

        Patients with Primary IGFD present with extreme short stature (height standard deviation score, SDS < -3) and an extremely poor prognosis for adult stature. Whereas prepubertal height SDS can range as low as -9, a blunted pubertal growth spurt is usually apparent, resulting in adult height that is typically 5-12 SD's below the normal population (adult height between 100 and 140 cm). The profound short stature in patients is often associated with severe psychosocial problems.


        SOURCE: Insmed Incorporated



        E-Mail this DGNews to a colleague   To print, use this version






        All contents Copyright (c) 1995-2009 Doctor's Guide Publishing Limited. All rights reserved.



        The NTK initiative. Physicians helping physicians identify Need-To-Know science
           Feedback
        Please rate this article: Strongly DISAGREE...Strongly AGREE NTK logo
        Question 1 - Physicians need to become aware of this information as soon as possible. Question 2 - This information is likely to have an impact on the way physicians practice medicine.
        1
        2
        3
        4
        5
        6
        7
        Send