FDA approves rheumatoid arthritis treatment
ATLANTA The Food and Drug Administration has approved a biotech drug for adults with moderate to severe rheumatoid arthritis.
UCB announced the approval of Cimzia (certolizumab pegol) based on clinical trials in which patients took the drug with Barr Labs’ Trexall (methotrexate) and experienced a significant reduction in the signs and symptoms of RA after 24 weeks, with some showing clinical responses within one or two weeks, compared with Trexall alone.
“The approval of Cimzia for moderate to severe rheumatoid arthritis in the U.S. is a major milestone for UCB and, most importantly, for people seeking a new treatment option to manage this debilitating condition,” UCB CEO Roch Doliveux stated. “UCB is committed to developing new therapies, such as Cimzia, to help meet the needs of patients living with rheumatoid arthritis and other immune diseases.”
Vistakon launches Acuvue Direct program
JACKSONVILLE, Fla. People who wear a brand of contact lenses will have a new way to buy annual supplies of them.
Vistakon, part of Johnson & Johnson’s eye-care division, has launched the Acuvue Direct program for wearers of Acuvue lenses, allowing them to receive four three-month supplies of the lenses and spread the cost over the year instead of paying for a full year’s supply upfront. The program is based on research indicating that for many patients, the up-front cost of buying an annual supply of contact lenses is more than they can afford.
“Too often, contact lens wearers wear their lenses longer than they should simply because they forget to order more when they begin to run low,” Vistakon director of medical affairs Sheila Hickson-Curran stated. “Getting that automatic shipment in the mail is a good visual reminder that encourages better compliance.”
Takeda Pharmaceutical receives FDA approval for Type 2 diabetes drug
DEERFIELD, Ill. A subsidiary of a Japan-based company announced the FDA approval of an extended-release version of the combination medication ACTOplus met (pioglitazone HCl and metformin HCl) as an adjunct to diet and exercise for the treatment of Type 2 diabetes.
Takeda Pharmaceutical North America’s ACTOplus met XR is the first and only prescription oral antidiabetic fixed-dose combination medication available with the extended-release form of metformin to help improve glycemic control in a convenient, once-daily dosing option.
ACTOplus met XR is indicated for adults with type 2 diabetes who are already treated with ACTOS (pioglitazone HCl) and metformin or who have inadequate glycemic control on ACTOS or metformin alone.
ACTOplus met XR combines ACTOS and metformin, two widely-used medications in a single tablet. ACTOS directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces. Metformin acts by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
Extended-release metformin, one of the active ingredients in ACTOplus met XR, was developed by Watson Laboratories, a subsidiary of Watson Pharmaceuticals and licensed to Takeda Pharmaceutical. Takeda expects ACTOplus met XR to be available later this calendar year.