Chiselling ingrates...
ABBOTT PARK, Ill., Dec. 30 /PRNewswire-FirstCall/ -- HUMIRA® (adalimumab), the latest biologic therapy and first fully human monoclonal antibody for the treatment of rheumatoid arthritis (RA), was prescribed to more than 40,000 patients suffering from the potentially crippling joint disease during its first year on the market. Approved by the U.S. Food and Drug Administration (FDA) on December 31, 2002, HUMIRA is the most successful product launch in the Abbott's 115-year history.
"The success of HUMIRA in its first year confirms it is a treatment meeting an important need for patients and physicians," said Tim Walbert, divisional vice president and general manager, Abbott Immunology. "It is a reflection of Abbott's larger commitment to providing patients with the most innovative treatments science has to offer."
At the time of its regulatory submission, HUMIRA was the most studied biologic therapy for RA, with 23 clinical trials involving more than 2,400 patients. HUMIRA was FDA approved earlier than anticipated, just nine months after the company's regulatory submissions in the United States and Europe.
"The benefits of HUMIRA for my patients have been remarkable," said Charles A. Birbara, M.D., medical director of the Clinical Pharmacology Study Group at the University of Massachusetts City Campus, Worcester, Mass. "Before starting HUMIRA, some patients couldn't dress themselves or hold their children or grandchildren. HUMIRA has given them their lives back, with some patients responding as early as one week after their first dose."
HUMIRA offers convenient administration that is unmatched by available biologic medications. It is packaged in a pre-filled syringe specially designed for easy use at home by people with RA. The design, which has been tested with RA patients and received the Arthritis Foundation's Ease-of-Use Commendation seal, features unique plastic wings that are easy to hold and allows patients to self-administer their medication without having to mix or measure it. HUMIRA offers patients convenient dosing (typically every other week), with 75 percent fewer injections than another commonly prescribed self- injected RA treatment.
"I had my first injection on a Friday in mid-April," said Tecela Harris, HUMIRA patient. "After just five HUMIRA injections, I felt total improvement, physically and mentally. My knees and hands weren't swollen, and my watch and rings were loose. I wasn't stiff or hunched over when I woke up."
Key HUMIRA Milestones in 2003
Patient Access. In conjunction with the product launch in January, Abbott launched its Medicare Assistance Program, an unprecedented drug-access initiative that provides HUMIRA at no cost to Medicare-eligible seniors. Recently, Congress passed a new Medicare drug benefit, and -- as part of that legislation -- has included a two-year demonstration project that will allow for reimbursement of self-injectable drugs. Once the details of the demonstration project are determined, Abbott will help program participants transition to the project. Until then, Abbott will continue to offer HUMIRA free to eligible seniors through its Medicare Assistance Program.
RA Clinical Studies. Data presented at the European League Against Rheumatism (EULAR) meeting in June showed HUMIRA was effective in early RA; at the October American College of Rheumatology (ACR) annual meeting, studies showed that HUMIRA taken alone or in combination with methotrexate (MTX) exhibits sustained response for up to five years in adult patients with active RA. In addition, data showed that HUMIRA significantly improved the quality of life for people living with RA, including physical function, bodily pain and fatigue. It is the only biologic DMARD to demonstrate statistically significant reduction in fatigue in RA patients.
Additional Clinical Studies. In 2003, HUMIRA trials were announced in psoriatic arthritis, juvenile rheumatoid arthritis, psoriasis, and Crohn's. Phase III studies in ankylosing spondylitis will begin shortly.
Regulatory Milestones. The European Commission granted marketing authorization of HUMIRA in September for the treatment of adult RA. With E.U. marketing authorization, HUMIRA became the first human monoclonal antibody approved for RA in Europe and the first TNF antagonist approved with an indication for use with methotrexate or as monotherapy. In October, Abbott submitted to the FDA a supplemental Biologics Licensing Application (sBLA) seeking approval for the use of HUMIRA to improve physical function in patients with moderately to severely active RA.
Financial Performance. Abbott raised HUMIRA sales expectations twice during 2003. Abbott set its total 2003 sales expectations for HUMIRA at more $250 million worldwide. Also, HUMIRA became Abbott's most successful product launch in its 115-year history.
Awards. HUMIRA was named the Best New Medicine of 2003 by Med Ad News. In addition, HUMIRA was named one of Chicago's most innovative and successful products. One of 10 winners, HUMIRA was chosen among 130 submissions as a recipient of the 2003 Chicago Innovation Award, which honors local companies for their novel products and services. The award is sponsored by the Chicago Sun-Times and Kuczmarski & Associates.... |
