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Shire plc, the global specialty biopharmaceutical company, announced last month that the Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended, by a vote of twelve to one, that the efficacy and safety data provided substantial evidence to support approval of FIRAZYR(R) (icatibant injection) for the treatment of acute attacks of HAE in patients 18 years and older. In addition, by a vote of eleven to one, with one abstention, the Committee recommended self-administration of the drug by patients. Mapi Values played a key part in the validation of the primary and key secondary endpoints for the trials.
Shire partnered with Mapi Values to validate the patient reported outcomes (PRO) strategy for FIRAZYR, drawing upon the extensive experience of Mapi Values in developing PRO evidence for FDA review. Mapi Values helped Shire ensure that the clinical trial program included an appropriate questionnaire to allow collection of robust patient reported evidence in HAE, ultimately compiling a clear case for validity of the PRO endpoints and helping define the efficacy of FIRAZYR.
Linda Abetz led the Mapi Values team, offering strategic advice, conducting the patient research and helping develop and submit briefing materials for the FDA Advisory Committee meeting. Following the positive announcement from the Advisory Committee, Linda said ‘This was a whole team effort, with involvement across the globe to ensure all versions of the diary across the trials met the strict criteria in the FDA PRO guidance. We are delighted that the result was successful as our patient research also suggested that patients really needed a drug they can self-administer quickly when suffering from HAE attacks.’
Shire had previously garnered EMA approval for FIRAZYR in 2009 following submission trial and PRO evidence. Strategic consulting on the self-administration trial in Europe on patient education materials also helped to gain approval in Europe for self-administration in Feb 2011 and for advisory committee approval in the US.
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