FDA gives breakthrough therapy designation to experimental hepatitis C regimen
NORTH CHICAGO, Ill. — An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.
AbbVie said the FDA granted breakthrough therapy designation to its direct-acting antiviral, or DAA combination drug therapy consisting of three drugs, which go under the code names ABT-450/r, ABT-267 and ABT-333, with or without the common antiviral drug ribavirin. The agency uses breakthrough therapy designation to promote expedited development and review of drugs for serious or life-threatening conditions that have the potential to significantly improve treatment. The drug is part of a therapy regimen that would allow for elimination of interferons, biotech drugs for hepatitis C that, while effective, also carry harmful side effects.
The drug currently is in phase-3, or late-stage clinical development, and the FDA designation was granted on the basis of results from a phase-2b trial titled "Aviator," in 571 patients.
The drug maker said that after 12 weeks of treatment, a high rate of patients who had not received treatment for hepatitis C before or who had failed treatment with combination interferon and ribavirin therapies had shown high sustained viral response, or SVR rates, essentially meaning they were cured. This included 99% of those who had not received treatment and 93% of those who had failed interferon-ribavirin treatment, with only one relapse and four of the 247 patients treated for 12 and 24 weeks with triple DAA and ribavirin dropping out due to harmful side effects.
Sam’s Club offers skin, weight, stress screenings
BENTONVILLE, Ark. — Sam’s Club is offering free skin and weight screenings during the weekend, the club retailer said Monday.
Sam’s Club said all of its stores that operate pharmacies would offer the screenings, as well as screenings for the effects of stress on both, on Saturday. The screenings include body mass index, blood tests for the stress hormone cortisol, weight, height, blood pressure and vision. The stores also will give away certificates for free samples of the probiotic supplement Align.
"As summer arrives, Americans are more focused on getting in shape and spending more time in the sun," Sam’s Club SVP health and wellness Jill Turner-Mitchael said. "Sam’s Cub is hosting preventive weight maintenance, stress and skin health screenings to help people prevent potential skin damage from the sun and understand the effects that stress and cortisol levels may have on weight and skin maintenance."
Rite Aid to launch sixth annual Healthy Skin Tour
CAMP HILL, Pa. — Rite Aid is sending out a customized 38-ft. van to 50 stores around the country as part of a campaign to promote skin care.
The retail pharmacy chain announced Monday the start of the Road to Healthy Skin Tour, which it is sponsoring on behalf of the Skin Cancer Foundation to coincide with Skin Cancer Awareness Month. The tour is in its sixth year and will visit Rite Aid stores in the Northeast, Midwest, South and West.
The tour will start on May 14 and run through August, offering free, full-body skin cancer screenings at stores and offering education about prevention and detection. Since its 2008 inception, the tour has detected nearly 7,000 suspected cancers and precancers, including nearly 300 cases of melanoma.
"By bringing free screenings like these into the communities we serve, Rite Aid is affirming its commitment to supporting customers’ long-term health goals and continuing its transformation into a network of neighborhood health and wellness destinations," Rite Aid EVP pharmacy Robert Thompson said.