Cambridge, Mass. – June 3, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that new data on the cardiovascular (CV) safety of its investigational-stage candidate, prucalopride, will be shared as an oral presentation at the 2018 Digestive Disease Week (DDW) annual meeting (June 2-5, 2018; Washington, D.C.). Prucalopride, a serotonin type 4 (5-HT4) receptor agonist2, is being evaluated by the U.S. Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults.
“We are pleased that these data will be shared with physicians at the DDW annual meeting because they demonstrate important results about the cardiovascular safety profile of prucalopride and Shire’s commitment to addressing unmet treatment needs in GI,” said Andreas Busch, Ph.D., Head of Research and Development, Shire. “Chronic idiopathic constipation affects an estimated 35 million people in the U.S.3,4*, and can potentially impact a person’s life.5 If approved, prucalopride will be the only readily available 5-HT4 agonist2 in the U.S. to treat adults with CIC.”
Shire sponsored an observational, pharmacoepidemiology safety study to estimate the risk, as measured by the pooled adjusted incidence rate ratio (IRR), of major adverse CV events (MACE) in adult new users of prucalopride compared to adult new users of polyethylene glycol (PEG). MACE included hospitalization for acute myocardial infarction or stroke and in-hospital CV death. Study data was from real-world settings in the United Kingdom and Sweden. This pooled analysis included over 35,000 patients with chronic constipation treated with prucalopride or PEG in a 1- to- 5 ratio. The average total duration of use was over 170 days for prucalopride and over 80 days for PEG. The pooled adjusted IRR for MACE was 0.64 (95% CI, 0.36, 1.13) in this mostly female (>90%) patient population where many were aged 55 years or younger, which was consistent with no evidence of an overall increase in the risk of MACE in patients using prucalopride compared with PEG.1
“Because prior 5-HT4 agonists have been associated with adverse cardiovascular events in the past, further evaluating the risk of MACE in patients taking prucalopride was important,” said Alicia Gilsenan, Ph.D., Senior Director, Epidemiology, RTI Health Solutions, one of the lead researchers of this study. “Findings from this cohort study have provided us with real-world evidence from a large patient population about the cardiovascular safety profile of prucalopride compared with polyethylene glycol.”
Details for the oral presentation are:
Non-Interventional Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort Initiating Polyethylene Glycol 3350 (PEG)
Sunday, June 3, 2018
2:45 p.m. - 3:00 p.m.
Session Number: 2530; Presentation Number: 386
Ballroom B - Washington Convention Center
Details for the poster presentations:
In addition to the oral presentation, two posters on chronic idiopathic constipation will be presented, contributing to the body of evidence about CIC, which affects an estimated 35 million people in the U.S.3, 4*:
The Economic Burden of Chronic Idiopathic Constipation in the U.S.: A Systematic Literature Review – Poster Presentation
Monday, June 4, 2018
12:00 p.m. - 2:00 p.m.
Session Number: 7165; Presentation Number: Mo1574
Patterns of Pharmacotherapy in Patients with Chronic Idiopathic Constipation Initiating Treatment with Linaclotide or Lubiprostone – Poster Presentation
Monday, June 4, 2018
12:00 p.m. - 2:00 p.m.
Session Number: 7165; Presentation Number: Mo1573
About the Oral Presentation
Data for this noninterventional, population-based cohort study were collected from four data sources – three from the United Kingdom and one from Sweden and included over 35,000 patients with chronic constipation treated with prucalopride or PEG. Patients were identified using electronic medical records, administrative claims, or national health-data registers. MACE outcomes in the UK were validated using additional clinical data, as available, and adjudicated by a committee of three clinicians. In Sweden, MACE outcomes were identified using previously validated algorithms. In all data sources, >90% of participants were women, and the proportion of patients aged ≥55 years was 21%-34% for UK data sources and 53% in Sweden.1
Prucalopride, a serotonin type 4 (5-HT4) receptor agonist2, is a gastrointestinal prokinetic agent that stimulates colonic peristalsis, increasing bowel motility.6,7 It is an investigational compound, and has not been approved for use by the U.S. Food and Drug Administration.
Prucalopride is currently approved and available in the European Union (EU) where it is marketed by Shire as Resolor®, indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.8 Prucalopride is also available in several other countries outside of Europe.
On March 5, 2018, Shire announced that the U. S. Food and Drug Administration (FDA) accepted the submission of a new drug application (NDA) for prucalopride as a potential once-daily treatment option for CIC in adults. The FDA is expected to provide a decision on or around December 21, 2018, the designated Prescription Drug User Fee Act (PDUFA) action date. Prucalopride has been studied in more than 90 clinical trials worldwide over the last 20 years, including five main Phase 3 and one Phase 4 double-blind, placebo-controlled clinical trials along with this observational, pharmacoepidemiology CV safety study, which informed the NDA submission.9
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Shire is the global biotechnology leader serving patients with rare diseases and specialized conditions. We seek to push boundaries through discovering and delivering new possibilities for patient communities who often have few or no other champions. Relentlessly on the edge of what’s next, we are serial innovators with a diverse pipeline offering fresh thinking and new hope. Serving patients and partnering with healthcare communities in over 100 countries, we strive to be part of the entire patient journey to enable earlier diagnosis, raise standards of care, accelerate access to treatment, and support patients. Our Rare Disease and Neuroscience divisions support our diverse portfolio of therapeutic areas, including Immunology, Hematology, Genetic Diseases, Internal Medicine, Ophthalmics, Oncology, and neuropsychiatry disorders.
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a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.
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* This represents ~14% of the U.S. population as of July 1, 2016 Census Bureau Data.