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Pfizer gains fast track designation for investigational C. difficile vaccine

BY Michael Johnsen

NEW YORK — Pfizer last week announced that the Food and Drug Administration has granted fast track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). 
 
Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.
 
“C. difficile is a growing, difficult-to-treat healthcare-associated infection,” stated Emilio Emini, SVP Vaccine Research and Development for Pfizer. “No vaccine is currently available to prevent the infection-associated disease. In the United States alone, there are approximately 250,000 cases of C. difficile-associated disease, resulting in approximately 14,000 deaths each year.”
 
The FDA’s fast track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
 
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CRNF releases report touting the important heart-healthy benefits of phytosterols

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition Foundation on Thursday released a report touting the important heart-healthy benefits of phytosterols — compounds found in plants that can lower cholesterol. The report also indicated that taking phytosterol dietary supplements at preventive intake levels may have a beneficial impact on healthcare costs by reducing the potential for a coronary heart disease-related medical event.
 
The report, “Smart Prevention — Health Care Cost Savings Resulting from the Targeted Use of Dietary Supplements,” conducted by Frost & Sullivan through a grant from the CRNF, found that if the targeted population — U.S. adults over the age of 55 years with CHD — takes phytosterol dietary supplements at the preventive intake levels identified in the report, it can lead to individual and societal healthcare savings by reducing risk of CHD-related medical events by more than 11%.
 
“According to the economic report, for those currently suffering from CHD, it’s financially prudent to include phytosterols to help prevent medical events associated with the disease," stated Steve Mister, CRNF president. "Medical events are expensive; this report tells us it’s worth considering the 15 cents per day it costs to take phytosterols to help prevent these kinds of events in the first place.” 
 
According to the report, if U.S. adults over the age of 55 years with CHD take phytosterol dietary supplements, nearly 2.3 million CHD-related medical events could be avoided between 2013 and 2020, totaling $34 billion in avoided expenditures over the same time period. Less than 1% of adults over the age of 55 years take phytosterol dietary supplements, meaning almost 100% of this group still has yet to benefit. The number of adults ages 55 years and older with CHD is expected to rise 13% between 2013 and 2020.
 
According to Duffy MacKay, SVP scientific and regulatory affairs at the Council for Responsible Nutrition: “Elevated cholesterol is a risk factor for heart disease. Daily consumption of phytosterols can prevent cholesterol build-up in the body by inhibiting its absorption in the intestine.”
 
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Pfizer and Protalix BioTherapeutics announce approval of Type 1 Gaucher disease treatment

BY Michael Johnsen

NEW YORK — Pfizer and Protalix BioTherapeutics last week announced that the Food and Drug Administration approved Elelyso (taliglucerase alfa) for injection for pediatric patients.  Elelyso is therefore now indicated for long-term enzyme replacement therapy for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.
 
"The approval of Elelyso to treat pediatric patients with Type 1 Gaucher disease provides physicians another treatment option for this rare and potentially debilitating disease,” stated Rory O’Connor, SVP global medical affairs, Global Innovative Pharma Business at Pfizer. “This pediatric indication, along with the recent announcement that Elelyso received kosher certification by the Orthodox Union, reinforces the ongoing commitment of Pfizer to addressing the needs of the Gaucher community.”
 
The safety and efficacy of Elelyso were assessed in 14 pediatric patients with Type 1 Gaucher disease in two clinical trials. The recommended dosage of Elelyso for treatment of pediatric patients four years of age and older is 60 units/kg of body weight administered every other week as a 60 to 120 minute intravenous infusion. 
 
Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with Elelyso at that same dosage when they switch from imiglucerase to Elelyso. Dosage adjustments can be made based on achievement and maintenance of each patient’s therapeutic goals.
 
Serious hypersensitivity reactions, including anaphylaxis, have occurred in some patients treated with Elelyso. The most common adverse reactions for Elelyso in clinical trials were itching, flushing, headache, joint pain, pain in extremity, abdominal pain, vomiting, fatigue, back pain, dizziness, nausea and rash. Vomiting occurred more often in pediatric patients than adults. 
 
“While Type 1 Gaucher disease can manifest in childhood or adulthood, the disease more often presents during childhood,” noted Paige Kaplan, of the Section of Biochemical Genetics (Metabolic Diseases) at Children's Hospital of Philadelphia. “It is important that children with this disease have access to a range of FDA-approved treatment options that are effective.”  
 
As part of its ongoing commitment to helping address the unmet medical needs of people with rare diseases, Pfizer also offers a specialized support program — called Gaucher Personal Support — for people living with Gaucher disease. Pfizer GPS is a one-stop resource for personalized patient support and specialty pharmacy services for patients and healthcare professionals. Pfizer GPS employs a dedicated team of healthcare specialists who are available to help patients with Gaucher disease and their caregivers with reimbursement assistance, coordinating and locating infusion services and ongoing pharmacy support.  
 
Elelyso for injection is supplied as 200 units/vial and is available by prescription only. 
 
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