PHARMACY

Study: GSK’s FluLaval Quadrivalent reduces flu cases among children ages 3 years to 8 years by 55.4%

BY Michael Johnsen

PHILADELPHIA — GlaxoSmithKline on Wednesday announced that a peer-reviewed study issued online by the New England Journal of Medicine has reported that GSK’s FluLaval Quadrivalent reduced flu cases among children ages 3 years to 8 years by 55.4% overall and lowered the risk of developing moderate-to-serious flu illness by 73.1%. 

This was the first large-scale clinical trial conducted specifically to review the safety and effectiveness of vaccinating children with a four-strain flu vaccine. The randomized, controlled clinical trial included 5,220 children and was one of the pivotal studies leading to the recent approval of FluLaval Quadrivalent by the Food and Drug Administration.

“The U.S. Centers for Disease Control recommends all children get vaccinated each flu season. This is in response to how many children require flu-related medical care, and given that as many as 20,000 U.S. children are hospitalized each year due to complications of the flu,” stated Leonard Friedland, VP, director scientific affairs and public health, GSK Vaccines North America.  “This study provides robust safety and efficacy data on FluLaval Quadrivalent, and evidence of the clinical benefit of vaccination with FluLaval Quadrivalent as demonstrated by the prevention of moderate-to-severe cases of influenza among children.”                                                                       

Newly available quadrivalent flu vaccines protect against all four of the flu strains that are in circulation during a flu season. Until this flu season, flu vaccines were limited to protecting against three influenza strains, and this necessitated the World Health Organization and other public health authorities to estimate each year what three strains might be predominant.

Virus strains that scientists refer to as A-strains traditionally cause the most cases of flu, so two A strains have been included in seasonal flu vaccines. The other circulating strains, referred to as B-strains, derive from two distinct strain lineages. In six of the past 11 flu seasons, the B-strain included in flu vaccines was not the predominant B-strain in circulation. The new quadrivalent flu vaccines protect against both B strains, providing the broadest strain protection currently available.

GSK has developed two quadrivalent vaccines that the FDA has licensed for use. GSK markets these vaccines as FluLaval Quadrivalent and Fluarix Quadrivalent. Both vaccines are approved to be administered to individuals three years and older, and they have been shown to have comparable safety and tolerability to three-strain (trivalent) seasonal influenza vaccines.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

NCPA lobbies for MTM coverage under Medicare Part D

BY Michael Johnsen

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday urged U.S. Senators on the Senate Finance Committee to support a proposal — scheduled for a vote as soon as Thursday — intended to expand coverage in the Medicare Part D prescription drug program of medication therapy management programs.

“Community pharmacists are highly trained medication experts and expanding the MTM services that they provide can achieve better health outcomes and lower overall costs,” Douglas Hoey, NCPA CEO said. “The challenges of not adhering to prescription drug therapy are real and expensive, and pharmacist-delivered MTM services can make a world of difference for patients.”

The change is proposed by Sens. Pat Roberts, R-Kan., and Robert Casey, D-Penn., as an amendment to legislation before the Senate committee that would temporarily prevent cuts to Medicare payments to physicians. The Roberts-Casey amendment would require the U.S. Centers for Medicare and Medicaid Services to study whether the coverage of MTM services for patients with one chronic condition would reduce Medicare spending overall through the avoidance of costlier treatments such as hospitalizations. If CMS determines that the expansion in coverage would lower costs, then the expansion of MTM coverage would be required. Currently, only those patients suffering from specific multiple chronic conditions are eligible for MTM services.

Research indicates that the cost savings from MTM can be significant. One Minnesota study found a 12-to-1 return-on-investment for MTM.  In North Carolina, MTM programs helping seniors produced a 13-to-1 return.  

MTM involves pharmacists working with patients to review and monitor their medication plan to maximize its effectiveness and avoid potential health problems, ultimately helping to reduce costs in the long run.  

The Roberts-Casey amendment stems from bipartisan legislation (S. 557, the Medication Therapy Management Empowerment Act) introduced by Sen. Kay Hagan, D-N.C., and cosponsored by Casey, Roberts and 28 other senators.

 

 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

FDA approves generic versions of Cymbalta

BY Alaric DeArment

SILVER SPRING, Md. – The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said Wednesday.

The FDA announced the approval of generic duloxetine delayed-release capsules manufactured by Aurobindo Pharma, Dr. Reddy’s Labs, Lupin, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries and Torrent Pharmaceuticals.

The drug is a generic version of Eli Lilly’s Cymbalta. Cymbalta had sales of $4.7 billion in 2012, making it the fifth top-selling drug that year, according to IMS Health. In addition to depression, Cymbalta is used to treat pain resulting from diabetic peripheral neuropathy, fibromyalgia and other causes. Most of Lilly’s patents on Cymbalta expire this year or within the next couple of years, though its patent covering the use of the drug for fibromyalgia won’t expire until 2019, according to FDA records. 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?