FDA approves GlaxoSmithKline’s raxibacumab for anthrax
LONDON — The Food and Drug Administration has approved a new biotech drug from GlaxoSmithKline for anthrax, the drug maker said.
GSK announced the approval of raxibacumab for adults and children who have inhaled Bacillus anthracis. The drug is designed for combination with antibiotics and for preventing inhalational anthrax when alternative therapies aren’t available. The drug is the result of a project that Human Genome Sciences, now owned by GSK, began working on in 2001 in response to terrorist anthrax attacks in the United States.
"Raxibacumab is an important part of an ongoing collaboration between GSK and the U.S. government to address a range of public health concerns," GSK SVP and head of infectious diseases Zhi Hong said. "It will be an important addition to the new approaches required to address our critical biodefense needs."
NACDS recognizes U.S. Sen. Kay Hagan on behalf of pharmacy patient care
ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Monday recognized U.S. Sen. Kay Hagan (D-N.C.) for her continued leadership on behalf of pharmacy patient care. Hagan, joined by seven U.S. Senate colleagues, sent a bipartisan letter of support for medication therapy management to U.S. Senate Majority Leader Harry Reid and Minority Leader Mitch McConnell.
The letter urged inclusion of language in any end-of-year legislation that would allow seniors who suffer from any chronic disease to benefit from MTM services if the intervention could result in a cost savings to the Medicare program. Currently under Medicare Part D, seniors must have “multiple chronic conditions” and be prescribed “multiple medications” before they are eligible for MTM services.
“Only one-quarter of seniors currently has access to MTM, while many more can benefit from the service,” the letter stated. “Research shows that only 50% of patients properly adhere to their prescription drug therapy regimens, and poor adherence costs the nation approximately $290 billion a year, nearly 13% of total health expenditures.”
In the North Carolina “ChecKmeds” program, MTM helped 31,000 seniors optimize their drug therapy for a savings of $34 million — a return on investment of nearly 14-to-1.
“We believe the best way to make sure Americans use medications effectively is through professional services offered by pharmacists and other qualified healthcare providers, including ‘medication therapy management,’” the letter stated. “Evidence shows that MTM improves outcomes and reduces unnecessary medical costs.”
“As the sponsor of the Medication Therapy Management Empowerment Act, NACDS thanks Senator Hagan for her continued leadership and commitment to community pharmacy and patient care,” stated NACDS president and CEO Steve Anderson. “Community pharmacies can provide MTM services to help patients manage their health, especially for those who suffer from chronic conditions such as diabetes, hypertension, asthma or other conditions.”
FDA approves Novartis drug for Cushing’s disease
EAST HANOVER, N.J. — The Food and Drug Administration has approved a new drug to treat a rare but serious endocrine disorder.
Swiss drug maker Novartis announced the approval of Signifor (pasireotide), an injectable drug for treating Cushing’s disease in adults for whom pituitary surgery is not an option or has not been curative. Novartis said Signifor was the first drug to be approved in the United States that addresses the disease’s underlying mechanism.
The disease is a debilitating disorder that most commonly affects patients aged 20 to 50 and is caused by a benign pituitary tumor that leads to excessive amounts of the metabolic hormone cortisol, leading to weight gain, obesity, fatigue, weakness, high blood pressure, depression and anxiety.