FDA declines to approve Iluvien
ATLANTA — The Food and Drug Administration declined to approve a treatment for diabetic eye disease made by Alimera Sciences, the drug maker said Dec. 23.
In its complete response letter, the FDA requested additional safety and efficacy data for the drug, Iluvien (fluocinolone acetonide intravitreal insert), a treatment for diabetic macular edema, a problem that commonly affects people with diabetes.
The agency also reported that it had found problems with current good manufacturing practices during inspections in August and September 2010 of plants operated by two of Alimera’s third-party manufacturers. According to Alimera, the manufacturers are in the process of resolving the problems.
A complete response letter means that the FDA has finished reviewing an approval application for a drug but issues remain that preclude final approval.
“We appreciate the FDA’s efforts to complete a priority review of our NDA and look forward to working closely with the FDA toward approval of Iluvien for the treatment of DME,” said Dan Myers, Alimera president and CEO. “To expedite the process, we have requested a meeting with the FDA to clarify the path to regulatory approval.”
Giant Food gives customers Healthy Ideas
LANDOVER, Md. — Giant Food is helping customers stick to their New Year’s resolutions by emphasizing its product labeling system.
Healthy Ideas, which initially launched in January 2009, identifies healthy options for customers as they shop the aisles, and includes both perishable and nonperishable items, as well as private-label and national brands.
"Losing weight and eating better regularly rank as among the most common New Year’s resolutions," said Andrea Astrachan, consumer adviser for Giant Food. "There is no better place to make healthy choices than at the supermarket, and Giant is committed to helping our customers stay on track with their healthy-eating goals throughout the year."
CVS Caremark acquires Universal American
WOONSOCKET, R.I. — CVS Caremark is more than doubling the size of its Medicare Part D program by acquiring the Medicare Part D business of Universal American for roughly $1.25 billion.
Universal American’s Part D business currently serves about 1.9 million Medicare PDP members, while CVS Caremark serves roughly 1.2 million Medicare PDP members. This reflects current levels of membership and does not include 2011 auto assignment or the results of the annual enrollment period, which ended Dec. 31, 2010.
“[Today’s] transaction furthers CVS Caremark’s position as a significant player in one of the nation’s fastest-growing segments of the pharmacy benefit management industry. A growing portion of the country’s population will receive their prescription drug coverage under Medicare plans, driven both by age demographics and the anticipated shift of retirees from employer-based coverage to Medicare that will likely result from healthcare reform,” stated Per Lofberg, president of Caremark Pharmacy Services.
“The Medicare Part D program is integral to CVS Caremark’s long-term growth strategy," Lofberg added. "We believe that bringing together these two businesses will strengthen our competitive offerings, enabling us to provide Medicare beneficiaries with expanded products and services and lower the cost of pharmacy care.”
CVS Caremark expected the deal to be accretive to earnings per share in its first full year, and it is not expected to impact the previously announced dividend growth and share buyback initiatives.
The deal is expected to close by the end of the second quarter. Universal American also operates a Medicare Advantage business, which will be spun off to Universal American shareholders as a separate company at the time of closing.