Shire’s Lialda receives FDA approval
PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.
Shire announced the approval of Lialda (mesalamine) delayed-release tablets for the maintenance of remission in patients with the disease.
The drug was already approved for inducing remission in patients with ulcerative colitis, an inflammatory disease that affects the colon and causes chronic inflammation, sores and ulcers.
Sanofi begins shipping flu vaccine for 2011-2012 season
SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, on Monday announced that it has begun shipping its 2011-2012 Fluzone influenza virus vaccine in the United States. This shipment represents the first of approximately 70 million doses of seasonal influenza vaccine the company plans to deliver to the United States in the upcoming season.
"As the largest producer of influenza vaccine in the U.S., supplying more than 40% of the nation’s influenza vaccine, our goal is to continue supporting the fight against influenza by consistently delivering a reliable supply of influenza vaccine to U.S. healthcare providers," stated Damian Braga, SVP commercial operations at Sanofi Pasteur. "With the licensure of Fluzone Intradermal vaccine earlier this year and Fluzone High-Dose vaccine at the end of 2009, for the first time this season, Sanofi Pasteur will be offering four influenza vaccine options to help address the unique immunization needs of all age groups in support of public health recommendations for everyone 6 months of age and older to receive an annual influenza immunization."
Fluzone will be provided in two formulations: a 0.25-mL pediatric dose for children 6 months through 35 months of age, and a 0.5-mL dose for children and adults 36 months and older.
Fluzone High-Dose vaccine, which was a new vaccine available in limited quantities last season following licensure at the end of 2009, will be widely available this season for adults ages 65 years and older. Due to weaker immune systems, people ages 65 years and older often do not produce as many antibodies as younger people following influenza immunization. Fluzone High-Dose vaccine is specifically formulated to increase the antibody response in those ages 65 years and older.
Fluzone Intradermal vaccine, licensed for the first time in the United States in May, is the first influenza vaccine licensed in the United States that uses a microinjection system for intradermal delivery. Fluzone Intradermal vaccine features an ultra-fine needle that is 90% shorter than the typical needle used for intramuscular injection of influenza vaccine. Fluzone Intradermal vaccine is anticipated to be an attractive immunization option for adults ages 18 through 64 years, an age group that has among the lowest rates of immunization.
The first shipments consist of Fluzone and Fluzone High-Dose vaccines. Regular shipments to healthcare providers and their distributors will be ongoing with all healthcare providers who have placed reservations receiving initial shipments by August and completed orders by early October. Due to the more recent licensure of Fluzone Intradermal vaccine, doses of this vaccine will be limited for the 2011-2012 season and are anticipated to ship in late September through October.
HHS announces the winners of 2011 Healthy Living Innovation Awards
WASHINGTON — The Department of Health and Human Services on Friday announced the winners of an awards program that highlights innovative health promotion projects that have demonstrated a significant impact on the health of the community within the past three years.
Among the award winners was the YMCA of the USA, which had partnered with Walgreens and UnitedHealth Group on “Taking the YMCA’s Diabetes Prevention Program to Scale.” Nominated organizations had to have an innovative project in at least 1-of-3 health promotion areas: healthy weight, physical activity and nutrition. Awards were granted based on the criteria of creativity and innovation, leadership, sustainability, replicability and results/outcomes.
In little more than two years, the program has been scaled from one pilot site to 116 sites in 22 cities. The YDPP is based on the landmark U.S. Diabetes Prevention Program, funded by the National Institutes of Health and Centers for Disease Control and Prevention, which showed that with lifestyle changes and modest weight reduction, a person with prediabetes can prevent or delay the onset of the disease by 58%. Indiana University School of Medicine researchers were able to replicate the results of the U.S. DPP — which was conducted one-on-one in a clinical setting — in conjunction with the YMCA of Indianapolis and proved that Ys can foster the same kind of intervention, but in a group setting, for a cost of 75% less than the U.S. DPP, while achieving similar weight-loss results.
YDPP’s goals: Reduce body weight by 7% and increase physical activity to 150 minutes per week. A trained lifestyle coach helps participants change their lifestyle by learning about healthy eating, physical activity and other behavioral changes over 16 one-hour classroom sessions. After the initial 16 sessions, participants meet monthly for added support for maintenance.
Efforts to scale the YDPP began with CDC funding in 2009, and allowed the faith-based organization to translate the science to practice in 22 cities in 2010. In April 2010, Y-USA partnered with UnitedHealth Group and Walgreens to begin to cover the YDPP for insured members and employees. By the end of 2011, 50 Ys will offer the YDPP, the company projected.
Walgreens had been selected by the managed care organization UnitedHealth Group to participate in the alliance. In its role as a founding partner, Walgreens provided personalized coaching and counseling by trained pharmacists to help patients diagnosed with Type 2 diabetes manage their condition and improve adherence to their physicians’ treatment plans. Walgreens pharmacists — or, in selected markets, Take Care Health Systems nurse practitioners — provided diabetes education and behavioral intervention, risk-factor reduction, health promotion and regular examinations for early signs of complications, all in the convenient setting of a local pharmacy. UnitedHealth Group covered the services at no charge to plan participants enrolled in employer-provided health insurance plans, marking the first time in the country that a health plan paid for evidence-based diabetes prevention and control programs.
Winners will receive awards from the secretary of health and human services at a public recognition ceremony and will have the opportunity to present their innovations at a national conference in 2011.