GSK’s, Theravance’s Anoro Ellipta receives FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.
The FDA announced the approval of Anoro Ellipta (umeclidinium; vilanterol inhalation powder) as a once-per-day maintenance treatment for airflow obstruction in patients with COPD, a term that encompasses chronic bronchitis and emphysema; smoking is the leading cause of COPD in the United States.
"Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD," FDA Office of Drug Evaluation II director Curtis Rosebraugh said. "The availability of new, long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD."
The drug is a long-acting beta2-adrenergic agonist, or LABA, which is designed to improve breathing by relaxing the muscles of the airways to allow more air to flow into the lungs. The drug carries a boxed warning, the strongest FDA-mandated warning a product can have, that LABAs increase the risk of asthma-related death; the drug is not approved as a treatment for asthma, the FDA said.
UnitedHealthcare names 2013 Medication Adherence TIP Challenge winners
MINNETONKA, Minn. — UnitedHealthcare on Wednesday announced the winners of the 2013 UnitedHealthcare Medication Adherence Targeted Intervention Program Challenge benefiting the National Association of Chain Drug Stores Foundation. The company presented a $100,000 donation to the foundation on behalf of the winning pharmacies at the 15th annual NACDS Foundation Dinner in New York earlier this month.
UnitedHealthcare created the challenge to recognize the pharmacies in its network that have been most successful at helping its Medicare Advantage-Part D plan members take their prescription medications appropriately, thereby helping to enhance their health and wellbeing.
UnitedHealthcare donated $10,000 to the NACDS Foundation on behalf of each of the winning pharmacies — five in the large retail pharmacy chain category, and five in the small retail pharmacy chain and independent community pharmacy category.
The winning pharmacies in the large retail pharmacy chain category were:
- Fred’s Super Dollar;
- Giant Eagle; and
- New Albertson’s and Supervalu.
The winning pharmacies in the small retail pharmacy chain and independent community pharmacy category were:
- Discount Drug Mart;
- Navarro Discount Pharmacies;
- Kerr Drug;
- LI Script in Woodbury, N.Y.; and
- Sunshine State Pharmacy in Coral Springs, Fla.
“We are grateful for the generous donation from UnitedHealthcare and appreciate the opportunity to be the beneficiary of its unique competition to encourage medication adherence among members of its Medicare plans,” stated Kathleen Jaeger, president, NACDS Foundation.
The winners of the 2013 UnitedHealthcare Medication Adherence TIP Challenge markedly improved medication adherence among a group of UnitedHealthcare Medicare Advantage-Part D plan members.
UnitedHealthcare notified the participating pharmacies of customers who could benefit from medication therapy management services based on their risk for medication nonadherence. For example, customers with a pattern of not filling prescriptions or picking up refills were flagged for the participating pharmacies. Pharmacists then worked with these customers through one-on-one consultations to help address their individual barriers to medication adherence, such as cost of their medications, memory problems that cause patients to forget to take their medications or confusion related to the complexity of their medication regimens.
When appropriate, pharmacists also informed their customers’ physicians of opportunities to consider evidence-based therapy protocols that could benefit the customer.
The pharmacies in each challenge category were ranked based on their customers’ medication adherence rates. The top five pharmacies in each category were recognized as the winners.
“Seniors and other Medicare beneficiaries who follow their medication regimen as prescribed by their physician are taking an important step in achieving optimal well-being, and many of them turn to their pharmacist for help and guidance,” noted Jack Larsen, CEO of UnitedHealthcare Medicare & Retirement. “We applaud the winning pharmacies in our Medication Adherence TIP Challenge who take their role in helping to improve their customers’ health seriously.”
Serving nearly one in five Medicare beneficiaries, UnitedHealthcare Medicare and Retirement is the largest business dedicated to meeting the health and well-being needs of seniors and other beneficiaries. The company is the market leader in Medicare Advantage plans, Part D prescription drug plans and Medicare supplement plans.
Lupin launches generic HIV drug
BALTIMORE — Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.
Lupin’s U.S. subsidiary launched its generic version of ViiV Healthcare’s Trizivir (abacavir sulfate; lamivudine; zidovudine) tablets in the 300-mg/150-mg/300-mg strength. The launch follows a ruling by the U.S. District Court for the District of Delaware that the drug did not infringe on Viiv’s patent.
Trizivir had sales of about $111.6 million during the 12-month period that ended in September, according to IMS Health.