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Shire Delivers Strong 2012 Results and Reiterates Confidence in 2013
Date:2/14/2013

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  • On December 18, 2012 Shire announced a positive outcome from the European Decentralized Procedure for ELVANSE (to be known as TYVENSE® in Ireland). ELVANSE is indicated as part of a comprehensive treatment program for ADHD in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.

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LDX for the treatment of Binge Eating Disorder ("BED")

  • A Phase 3 clinical program to evaluate the efficacy and safety of LDX in adults with BED was initiated in Q4 2012.

LDX for the treatment of Negative Symptoms of Schizophrenia ("NSS")

  • A Phase 3 clinical program to evaluate the efficacy and safety of LDX as adjunctive treatment to antipsychotic medications on negative symptoms in adults who have persistent predominant NSS was initiated in Q4 2012.

FIRAZYR for the treatment for Angiotensin Converting Enzyme Inhibitor-Induced Angioedema ("ACE-I AE")

  • In December 2012, Shire submitted a supplemental Marketing Authorization Application to the European Medicines Agency ("EMA") seeking approval for FIRAZYR for the treatment of ACE-I AE in Europe. Depending upon the outcome of discussions with the US Food and Drug Administration ("FDA") about appropriate development pathways for FIRAZYR as a possible ACE-I AE treatment option, Phase 3 studies for the US market could begin in 2013.  

VPRIV for the treatment of Gaucher disease (Type 1)

  • In December 2012, Shire filed with the EMA in Europe for the VPRIV label to be updated with data regarding the impact of VPRIV on certain parameters of bone disease in Type 1 Gaucher patients.

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SOURCE Shire plc
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