Abbott’s Humira gets support for expanded use
WASHINGTON — A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.
According to published reports, the panel voted 15-2 that the benefits of Humira outweighed the risks in treating ulcerative colitis. However, the panel asked Abbott to conduct more studies upon Humira’s approval.
While it isn’t required to do so, the FDA typically follows panel recommendations. According to reports, a final decision is expected by the end of the year.
According to reports, the drug would only be used in people battling moderate to severe ulcerative colitis who have not had success with other medicines. If approved for ulcerative colitis, the drug maker said that Humira would be the first biologic drug that people could inject themselves.
Last November, the FDA rejected Abbott’s application for Humira in ulcerative colitis, asking for further information.
The blockbuster drug already is approved for six other conditions, including rheumatoid arthritis and Crohn’s disease.
FDA grants priority review of Zytiga sNDA
RARITAN, N.J. — The Food and Drug Administration has granted priority review to a supplemental new drug application for a drug developed by Janssen Research and Development.
Janssen Research and Development said the regulatory agency granted priority review for Zytiga (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer, who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy. Under the Prescription Drug User Fee Act, the FDA will aim to conclude its review within six months of the sNDA submission. The sNDA was submitted in June, the company said.
"We believe that men with mCRPC whose disease is asymptomatic or mildly symptomatic, for whom chemotherapy may not be immediately necessary, have limited treatment options and that this disease setting represents a critical unmet medical need," said Michael Meyers, VP and compound development team leader for Zytiga. "We are delighted the FDA has granted a priority review designation for our sNDA."
Coastal Wine Brands debuts Charonge
NAPA, Calif. — Coastal Wine Brands has debuted a new California white wine blended with natural orange flavor.
Charonge, which debuted last month, the wine is zestily fruity with fresh orange blossom, peach/apricot and yellow plum aromas. On the palate, it delivers crisp, wonderfully refreshing orange, papaya and yellow apple flavors that are enlivened in the wine’s long, snappy finish by a slight spritz, the company said.
Charonge carries a suggested retail price of $12 per bottle.