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Takeda’s Entyvio approved to treat moderately to severely active ulcerative colitis and Crohn’s disease

BY Michael Johnsen

DEERFIELD, Ill. — Takeda Pharmaceutical on Tuesday announced that the Food and Drug Administration simultaneously approved a new biologic therapy, Entyvio (vedolizumab), for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

"Patients with moderately to severely active ulcerative colitis or Crohn’s disease, and the healthcare professionals who care for them, need additional new treatment options," said Douglas Cole, president of Takeda Pharmaceuticals U.S.A. "Entyvio reflects an expansion of Takeda’s commitment to supporting patients with gastrointestinal disorders."

"Entyvio is a new option that works to block important contributors to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease," stated Stephen  Hanauer, medical director at the Digestive Health Center at Northwestern University Feinberg School of Medicine. "The clinical trial program evaluated the efficacy and safety profile of Entyvio and demonstrated that Entyvio has the potential to help adult patients with moderately to severely active UC or CD successfully manage their disease."

Entyvio is approved for inducing and maintaining clinical response and remission, improving endoscopic appearance of the mucosa and achieving corticosteroid-free remission in adult patients with moderately to severely active UC who have 1) had an inadequate response with, lost response to or were intolerant to a tumor necrosis factor blocker or immunomodulator or 2) had an inadequate response with, were intolerant to or demonstrated dependence on corticosteroids. 

Entyvio also is approved for achieving clinical response and remission, and achieving corticosteroid-free remission in adult patients with moderately to severely active CD who 1) have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator or 2) had an inadequate response with, were intolerant to or demonstrated dependence on corticosteroids.

The Entyvio dose regimen is 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.

 

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AsthmaMD launches AsthmaMD Peak Flow Meter

BY Michael Johnsen

ORLANDO, Fla. — AsthmaMD recently launched its first retail product, the AsthmaMD Peak Flow Meter. The AsthmaMD Peak Flow Meter works with the newest AsthmaMD app and MyAsthmaMD secure cloud portal for physicians to help asthma patients more accurately track symptoms and medication adherence to preempt an attack. The multi-tiered asthma management program integrates physician-prescribed asthma action plans individualized to the patient into a simple process, the company stated.

"The current adherence rate to Asthma Guidelines to have a written asthma action plan is only about 30% to 50%," stated Sam Pejham, co-creator of AsthmaMD. "AsthmaMD improves that by making it very simple and quick to create and edit an action plan with a simplified and sequential breakdown of each step in the individualized action plan."

AsthmaMD provides educational material within the app, on the peak flow device and within the new web portal to help bridge the knowledge gap on asthma education. By inputting a physician-recommended management plan, the app will help patients to maintain adherence with medication reminders and insight into the patient’s digital diary. The app also displays the information in graphs for a visual look at such areas as the patient’s level of control or if the patient has been regular in taking medication for various periods of time.

"The truth is that 55% of patients do not know they are having symptoms because they are not obvious until an asthma attack occurs," Pejham said. "Since it is important to monitor symptoms on a daily basis in order to preempt asthma attacks, our free program has the potential to reduce the $56 billion spent nationwide annually. The key is providing an easy tool with a simple and meaningful tracking journal. AsthmaMD users overall have an increased peak flow meter performance of 10%."

AsthmaMD also offers simple, secure sharing with doctors. Patients will be able to gather the most precise peak flow reading possible and share it with their healthcare provider.

AsthmaMD Peak Flow Meter is available in 15,000 retail pharmacies nationwide, including CVS and Walgreens.

 

 

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Practice Fusion launches real-time healthcare database Insight

BY Michael Johnsen

SAN FRANCISCO — Practice Fusion on Wednesday launched its real-time healthcare database, Insight. With Insight, physicians, researchers and analysts can access analysis sourced from a de-identified subset of more than 81 million patient records. Insight users can explore health and pharmaceutical market trends, including diagnoses across patient populations, all in real-time.

Offered free of charge, Insight is designed to provide a full perspective across the healthcare spectrum, from diagnosis to treatment, that can identify new research opportunities and market trends.

“Real-time patient health data has been kept under lock and key, both because of technology limitations and the companies monetizing that data at a high cost—until today,” stated Ryan Howard, CEO Practice Fusion. “Insight unleashes powerful, de-identified health data from tens of millions of real patients and more than 2,000 drug therapies in real time, at no cost. This is a hugely disruptive move in the health data industry.”

Covering diagnoses from seasonal infections like influenza to such chronic conditions as diabetes, Insight enables users to explore data to uncover:

  • The current and historical market share of prescription medications compared to other medications in that drug class;
  • Currently trending diagnoses for a real-time view of current outbreaks;
  • Diagnosis trends over time to uncover trends in seasonal infections;
  • Proportion of patients with a diagnosis by body-mass index, age group or sex; and
  • Top 100 diagnoses seen nationally on the Practice Fusion platform. 

Practice Fusion also offers a premium version of Insight for those looking for more in-depth, granular analyses. Features of the paid platform include:

  • Additional data views including: patient profile, prescriber profile, Rx switching and treatment flow; filters allowing the selection of specific patient subpopulations; and the ability to see any data view for that specific subpopulation;
  • Ability to view the market share of any prescription medication within a patient subpopulation; and
  • Custom-curated reports offering real-time and in-depth performance analyses of any drug therapy in the outpatient market, available by request. 

 

 

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