FDA approves Stelara
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating a chronic autoimmune disease that affects 6 million Americans.
The FDA announced Friday the approval of the plaque psoriasis drug Stelara (ustekinumab), made by Horsham, Pa.-based Johnson & Johnson subsidiary Centocor Ortho Biotech.
Plaque psoriasis causes overproduction of skin cells, resulting in thick patches of inflamed, scaly red skin.
“This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance,” FDA Center for Drug Evaluation and Research Office of Drug Evaluation III director Julie Beitz said in a statement.
Stelara, a monoclonal antibody, works by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation. Because it suppresses the immune system, however, use of the drug poses a risk of infection.
HIV vaccine ‘modestly effective’ in late-stage clinical trial
LYON, France A late-stage clinical trial may have turned up something that researchers have awaited for nearly 30 years: an HIV vaccine that works.
Sanofi Pasteur, the vaccines division of French drug maker Sanofi-Aventis, announced Thursday that results of a 16,000-patient phase 3 trial conducted in Thailand over the last six years, with sponsorship from the U.S. Army Surgeon General and execution by the Thai Ministry of Public Health, indicate that a two-vaccine regimen for HIV is safe and “modestly” effective in preventing infection by the virus that causes AIDS.
According to final results, to be presented in Paris next month, the prime-boost combination of Sanofi Pasteur’s ALVAC HIV and VaxGen’s AIDSVAX B/E lowered the rate of HIV infection by 31.2% compared with placebo.
“Albeit modest, the reduction of risk of HIV infection is statistically significant,” Sanofi Pasteur SVP research and development Michel DeWilde said in a statement. “This is the first concrete evidence, since the discovery of the virus in 1983, that a vaccine against HIV is eventually feasible.”
DeWilde said further work would be needed to develop and test a vaccine suitable for licensure and worldwide use.
Study finds chronic disease prevention reduces medical costs
NEW YORK Prevention of such chronic diseases as diabetes, obesity and high blood pressure improves the lives of older Americans and also reduces medical costs, a new study found.
The study, conducted by Dana Goldman of RAND Corp. and colleagues, appeared in the Sept. 17 online edition and in the November print issue of the American Journal of Public Health. The researchers looked at a group of adults ages 51 to 52, and found that life longevity when chronic diseases were avoided increased between 0.85 and 3.44 years, depending on which disease was prevented.
In addition to these findings, the researchers also found lifetime medical costs would be saved: Preventing obesity would save $7,168; preventing high blood pressure would save $13,702; and preventing diabetes would save $34,483. However, the lifetime medical costs for a person who quits smoking would be $15,959 higher, the researchers noted.
“Our data indicate that primary prevention could improve the health and longevity of future cohorts of elderly persons in the United States at a relatively low cost,” the researchers concluded.