Key Developments For Shire Plc
Shire Plc (SHPGY.O) (Nasdaq)
Shire plc Submits European MAA For Velaglucerase Alfa
Shire plc announced that it has submitted a MAA to the European Medicines Agency for velaglucerase alfa, the Company's enzyme replacement therapy in development for the treatment of Type I Gaucher disease. This is the third marketing application for velaglucerase alfa that has been submitted, with previous submissions in the United States and Canada.
Shire plc Announces Publication Of Open-Label Study On Coadministration Of INTUNIV
Shire plc announced new study results on INTUNIV (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone. The open-label study also assessed improvement of Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using the ADHD Rating Scale-IV (ADHD-RS-IV).( ) INTUNIV is a nonscheduled, once-daily selective alpha-2A agonist indicated for monotherapy treatment of ADHD in children and adolescents ages six to 17. An estimated 25%-30% of ADHD patients may not respond to the most commonly prescribed ADHD medications, methylphenidates and amphetamines, when used alone as ADHD treatment.
Shire plc Reports Findings From Analysis Examining Emotional Lability In Children With ADHD Taking Vyvanse (lisdexamfetamine dimesylate) Capsules CII
Shire plc announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged six to 12 years. The post hoc analysis showed that patients demonstrated an improvement in emotional lability composite CPRS-RS scores while taking Vyvanse as compared to placebo. These results were presented recently at a psychiatric meeting in Honolulu.
FDA Grants Priority Review For Shire plc's velaglucerase alfa For Type 1 Gaucher Disease
Shire plc announced that the United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa, the Company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the target review timing from 10 to six months. The FDA has issued an action date for the NDA of February 28, 2010 under the Prescription Drug User Fee Act (PDUFA).
Shire plc Announces Tolerability and Clinical Effects Results of Daytrana (methylphenidate transdermal system) from Study in Adolescents with ADHD
Shire plc announced findings from a Phase IIIb study of the tolerability and effectiveness of Daytrana (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). In addition, data regarding the pharmacokinetic profile of Daytrana in children and adolescents was also presented. In this study, Daytrana participants were titrated to their optimal dose over five weeks and were then maintained on that dose for an additional five months. Participants from a previous double-blind, seven week study were able to enroll. In this seven week study, Daytrana was shown to significantly improve ADHD symptoms as rated by clinicians and parents compared with placebo. The frequency of adverse events was typical of these seen in studies of oral methylphenidate in adolescents, with the exception of dermal reactions. The long term extension study evaluated four doses of the Daytrana patch worn for nine hours at alternating hips and used for about six months. Most adverse events were mild to moderate in intensity. The most commonly reported treatment-emergent adverse events reported by 5% or more of participants that received Daytrana were decreased appetite (11.0%); headache (10.1%); upper respiratory tract infection (10.1%); nasopharyngitis (inflammation of the nasal passages and of the upper part of the pharynx) (9.2%); and irritability (5.5%).
