Content about Astellas Pharma

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

Astellas Pharma US said it applied with the FDA for approval of tacrolimus extended-release capsules to prevent rejection of transplanted kidneys in adults and transplanted livers in men. The drug was approved in Europe in 2007 under the name Advagraf and under the name Graceptor in Japan in 2008; the drug has been approved in 69 countries so far.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug's approval.

The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.

WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

BURLINGTON, Mass. — An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.

The report, which the healthcare market research firm said it would publish later this month, found that linaclotide — made by Ironwood Pharmaceuticals, Forest Labs, Almirall and Astellas Pharma — would emerge as the market leader for IBS and achieve sales of $1.1 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan by 2019.

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.