FDA panel recommends new approval for Genentech eye drug
SILVER SPRING, Md. — A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.
Genentech, a subsidiary of Swiss drug maker Roche, said the FDA Dermatologic and Ophthalmic Drugs Advisory Committe’s 10 members had voted unanimously to recommend approval of Lucentis (ranibizumab) in the 0.3-mg dose for DME, while voting 8-2 to recommend approval of the 0.5-mg dose. The FDA is not required to follow advisory committee recommendations when deciding whether or not to approve a drug, but usually does. The agency is expected to make its decision on Aug. 10. Lucentis already is approved for treating wet age-related macular degeneration.
DME is an eye condition in people with diabetes that causes swelling of the retina and blurred vision, and is a major cause of vision loss and blindness in diabetics, affecting more than 560,000 people in the United States.
"The committee’s recommendation is an important step toward the goal of helping to redefine the standard of care for Americans with diabetic macular edema," Genentech chief medical officer and head of global product development Hal Barron said. "There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA’s decision."
Florida Pharmacy Association sues state health department over HMO contracts
TALLAHASSEE, Fla. — The Florida Pharmacy Association, together with a group of Medicaid patients, independent pharmacies and pharmacists from all over Florida, filed a lawsuit Thursday in Leon County Circuit Court against the Agency for Health Care Administration to seek to restore patient access to qualified Medicaid pharmacy providers.
The lawsuit seeks to stop the Agency from continuing to enter and enforce contracts with for-profit Health Management Organizations and other for-profit managed care organizations that have forced Medicaid patients, according to the complaint, "to use only out-of-state pharmacy conglomerates and their affiliated mandatory mail-order pharmacies."
Study: Men with prostate cancer more likely to die from other causes
BOSTON — Men diagnosed with prostate cancer are less likely to die from the disease than from such preventable conditions as heart disease, according to a new study from Harvard School of Public Health.
Published in the Journal of the National Cancer Institute, researchers examined causes of death among prostate cancer cases recorded in the U.S. Surveillance, Epidemiology and End Results program (which includes more than 490,000 men from 1973 to 2008) and the nationwide Swedish Cancer and Cause of Death registries (which included more than 210,000 men from 1961 to 2008). They found that among men diagnosed with the disease, prostate cancer accounted for 52% and 30% of all reported deaths in Sweden and in the United States, respectively; however, only 35% of Swedish men and 16% of U.S. men diagnosed with prostate cancer died from this disease.
The researchers also noted that in both populations, the risk of prostate cancer-specific death declined, while the risk of death from heart disease and non-prostate cancer remained constant. The five-year cumulative incidence of death from prostate cancer was 29% in Sweden and 11% in the United States.
"Our results are relevant for several million men living with prostate cancer in the United States," said first author Mara Epstein, a postdoctoral researcher at HSPH. "We hope this study will encourage physicians to use a prostate cancer diagnosis as a teachable moment to encourage a healthier lifestyle, which could improve the overall health of men with prostate cancer, increasing both the duration and quality of their life."