FDA advisory committee recommends approval of BI’s atrial fibrillation drug
RIDGEFIELD, Conn. A Food and Drug Administration advisory committee has recommended approval of a drug for patients with atrial fibrillation.
The FDA cardiovascular and renal drugs advisory committee voted unanimously to recommend approval for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), for preventing strokes in atrial fibrillation patients. For the last 50 years, warfarin has been the only oral anticoagulant drug available for this purpose.
An estimated 2.3 million Americans have atrial fibrillation, and the prevalence is expected to increase to 5.6 million by 2050, according to a 2001 study published in the Journal of the American Medical Association.
An FDA advisory committee recommendation doesn’t guarantee approval for a drug, but is taken into account when the agency decides whether or not to grant approval.
Genentech amends approval application for expanded use of Avastin
SOUTH SAN FRANCISCO, Calif. Biotech company Genentech has amended its application to the Food and Drug Administration seeking an additional approval for one of its drugs, which the FDA has deemed a “major amendment,” Genentech said Monday.
Genentech, part of Swiss drug maker Roche, is seeking approval for Avastin (bevacizumab) combined with paclitaxel chemotherapy for untreated advanced breast cancer without the HER2 protein. The FDA has granted accelerated approval to Genentech’s application, and the company expects the agency to take action by Dec. 17. The expected action date is based on the FDA’s decision to extend its review period in light of the amendment.
“We are pleased by the FDA’s decision to review additional information on Avastin and are committed to working with the agency during this extended review period,” Genentech EVP product development and chief medical officer Hal Barron said.
Avastin already is approved for treating cancers of the colon and rectum, lungs and kidneys.
Kroger commences Giving Hope a Hand campaign for breast cancer
CINCINNATI Kroger’s family of stores will showcase breast cancer survivors in its annual Giving Hope a Hand campaign to support breast cancer initiatives in communities across the country.
This year, 56 women share their stories of survival on marketing materials and custom packages of national and Kroger brand items, which will be sold exclusively in Kroger’s family of stores. Kroger’s campaign includes a storewide sales promotion of popular items, many of which will feature exclusive, specially marked pink packaging. This year, 1,800 items, including Kroger’s own products and popular items from such Kroger partners as Pepsi, Kellogg, Kraft, General Mills, Procter & Gamble and Kimberly Clark will be marked with special pink shelf tags to highlight their participation.
“All of us at Kroger applaud these terrific associates for choosing to share their personal stories of fighting breast cancer with our customers and associates,” said David Dillon, Kroger’s chairman and CEO. “We are pleased to have our great people featured in our annual campaign, as they inspire others to take care of themselves and each other.”