FDA approves Merz’s Xeomin
GREENSBORO, N.C. The Food and Drug Administration has approved a treatment for muscle spasms and twitches.
Merz Pharmaceuticals announced Monday the approval of Xeomin (incobotulinumtoxinA), a treatment for cervical dystonia and blepharospasm. Cervical dystonia and blepharospasm belong to a class of disorders known as focal dystonias, which cause sustained muscle contractions resulting in twisting and repetitive movements, affecting the neck and eyelids, respectively. Focal dystonias affect around 295-out-of-every-1-million Americans, according to an epidemiology study conducted in Rochester, Minn.
“This is an important regulatory milestone for Xeomin and is key to establishing our neurology business in the U.S.,” Merz Pharmaceuticals president and CEO Jack Britts said. “We at Merz understand and are committed to addressing the complexities of treating and living with these neurological disorders.”
The drug is derived from botulinum toxin, the same basic ingredient of Allergan’s wrinkle treatment Botox (onabotulinumtoxinA), which is also used to treat focal dystonias.
NACDS urges FDA to move carefully in risk management rules for opioids
ROCKVILLE, Md. Note to the Food and Drug Administration from the chain pharmacy industry: when it comes to beefing up oversight and regulation of some high-risk medications, slow and steady is the best approach.
As the FDA mulls new, broad-based requirements on the dispensing and monitoring of all medications in the opioid class of painkillers, the National Association of Chain Drug Stores is weighing in with a cautious, if qualified, endorsement. That support came today from Kevin N. Nicholson, NACDS VP and pharmacy adviser for government affairs and public policy, who addressed a joint meeting of the FDA’s Anesthetic and Life Support Drugs Advisory and Drug Safety and Risk Management Advisory committees.
The meeting was set up to study the agency’s proposal to require all painkillers in the opioid class of medicines to follow the FDA’s Risk Evaluation and Mitigation Strategies guidelines. The agency first unveiled new REMS requirements for the makers of some higher-risk specialty medications in 2007. Thus far, the biggest target for those new REMS requirements has been the opioid class of painkillers, given their narcotic properties and the risks they carry for abuse and addiction.
Nicholson told the joint panel that NACDS "supports the measured approach to REMS that the FDA appears to be embracing, as evidenced by the FDA’s proposal for the classwide opioid REMS." However, he added, "The FDA must carefully navigate between mitigating the risks of these medications while also not negatively impacting patient care."
"We are pleased that the proposed REMS for long acting and extended release opioids follows the advice of stakeholders that emphasizes caution and deliberation over speed," said the NACDS executive. "Take time to develop the REMS and allow for stakeholder input to prevent negative consequences."
Beacon Community program seeks to curb diabetes across country
WASHINGTON Vice President Joe Biden and the Department of Health and Human Services secretary Kathleen Sebelius have announced a pilot program designed to curb diabetes in 15 selected U.S. cities with the help of health-information technology.
The Beacon Community program will use health IT resources within their community as a foundation for bringing doctors, hospitals, community health programs, federal programs and patients together to design new ways of improving quality and efficiency to benefit patients and taxpayers, the White House said in a release. Each Beacon Community has elected specific and measurable improvement goals in each of three vital areas for health systems improvement: quality, cost-efficiency, and population health. The goals vary according to the needs and priorities of each community.
Communities will use their Beacon Community awards to provide better control of blood pressure for diabetic and hypertensive patients, improvements in care coordination and chronic disease management, reductions in preventable emergency department visits and re-hospitalizations, reductions in health disparities, better rates of immunization for children and adults, and better adherence to smoking cessation and appropriate cancer screening guidelines, the White House said in a release. The Beacon projects are expected to initially create dozens of new jobs in each community paying an average of $70,000 per year for a total of 1,100 jobs up-front, while accelerating development of a nationwide health IT infrastructure that will eventually employ tens of thousands of Americans.
Cities included in the program are: Tulsa, Okla.; Stoneville, Miss.; Brewer, Maine; Danville, Pa.; Salt Lake City; Indianapolis; Spokane, Wash.; Rochester, Minn.; Providence, R.I.; Junction, Colo.; Concord, N.C.; San Diego; Hilo, Hawaii; and Buffalo, N.Y.
“The most important healthcare innovations are those that are designed and tested by providers and community leaders all across the country. Beacon Communities will offer insight into how health IT can make a real difference in the delivery of health care,” said Secretary Sebelius. “The Beacon Community Program will tap the best ideas across America and demonstrate the enormous benefit health IT will have to improving health and care within our communities.”