AstraZeneca applies to FDA to expand age group for Symbicort
WILMINGTON, Del. AstraZeneca has submitted a supplemental application to the Food and Drug Administration for approval of a new indication of its asthma-management drug Symbicort, the company announced Wednesday.
The drug has already been approved for use in children age 12 and older, but a study comprising five phase III trials of 1,446 children age 6 to 11, using pressurized metered-dose inhalers of Symbicort, found it to be as safe as dry-powder inhalers. The children in the study had previously used corticosteroid inhalers.
Sales of Symbicort reached $1.575 billion in 2007, according to AstraZeneca’s annual report.
FDA, EMEA partner on inspections program
WASHINGTON The Food and Drug Administration and the European Medicines Agency have joined together to pilot a good manufacturing practice inspections program.
Under the bilateral agreement, the program will apply to facilities in both the U.S. and the European Union. Also, joint inspections of active pharmaceutical ingredient facilities in countries outside the U.S. and the EU will be part of the program.
The agencies will pilot a GMP information exchange covering inspection schedules and results. Information on facilities that have been inspected would be shared so the agencies could get greater inspection coverage and better identify API production sites in countries outside the U.S. and the EU.
“The collaboration on inspections should result in more effective use of resources and a higher safety level of product from third countries,” the European Commission, which lists new GMP initiatives the two agencies undertake, said.
Study shows Mass. plan drops uninsurance rate, decreases expenses
CHICAGO According to a study performed by the Urban Institute, the uninsurance rate for Massachusetts adults has dropped by more than half and residents were paying less in out-of-pocket health expenses, as reported by the Associated Press.
Researchers from the institute interviewed 3,000 Massachusetts residents in the fall of 2006, just before the law took effect, and conducted a second round of interviews a year later. The uninsurance rate among working age adults dropped from 13 to 7 percent. The biggest drop was among poorer residents.
The finding reflects the fact that nearly 350,000 residents have been added to the ranks of the insured in Massachusetts under the law, which created a subsidized health care program for those earning less than three times the federal poverty level.
The share of adults reporting out-of-pocket expenses of more than $500 dropped by four percent. The percent of low-income adults reporting out-of-pocket expenses of more than $3,000 fell eight percent.
In another positive finding, low-income adults were more likely to have a place to go when they were sick and were more likely to visit a doctor for preventative care.
One fear—that employers would begin dropping health coverage as the new law took effect—hasn’t materialized, according to the report.