Focus on Arthritis

Arthritis drug news

Just-approved Humira arthritis drug free to eligible seniors until Medicare benefit enacted

ABBOTT PARK, ILL ,January,6 2003 -- Hard on the heels of earlier-than-expected FDA approval and shipping of supplies to pharmacies, Abbott Laboratories announced the launch of the Humira Medicare Assistance Program, an unprecedented drug access program that will provide its newly approved rheumatoid arthritis (RA) drug, Humira (adalimumab), at no cost to Medicare-eligible seniors without prescription drug coverage until a Medicare drug benefit is enacted

Humira, approved by the FDA on New Year's Eve, is the first human monoclonal antibody approved for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active RA who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs).

Humira was created using phage display technology, resulting in an antibody with human-derived heavy and light chains variable regions and human IgG1:K constant regions.

"Humira is an example of the positive impact pharmaceutical innovation can have for people living with chronic and debilitating conditions like RA," said Miles D. White, chairman and chief executive officer, Abbott Laboratories. "To reinforce Abbott's commitment to providing access to our medications, we're initiating the Humira Medicare Assistance Program to help remove barriers to this important new medicine for seniors with RA."

Humira, approved by the FDA on New Year's Eve, is the first human monoclonal antibody approved for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active RA who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs).

Humira was created using phage display technology, resulting in an antibody with human-derived heavy and light chains variable regions and human IgG1:K constant regions.

"Humira is an example of the positive impact pharmaceutical innovation can have for people living with chronic and debilitating conditions like RA," said Miles D. White, chairman and chief executive officer, Abbott Laboratories. "To reinforce Abbott's commitment to providing access to our medications, we're initiating the Humira Medicare Assistance Program to help remove barriers to this important new medicine for seniors with RA."

Abbott's Humira Medicare Assistance Program ensures that Medicare-eligible seniors in need of a biologic treatment for RA who do not have prescription drug coverage will be able to receive Humira at no cost until a Medicare prescription drug benefit is enacted. Seniors interested in the program should talk with their health care provider. Eligible seniors will receive Humira directly from their health care provider, and access will continue as long as they continue to meet the eligibility criteria. More information is available by calling 1-866-4-Humira.

"We always encourage companies to give seniors in need access to FDA approved drugs, like Abbott is doing with this new program," said Secretary Tommy G. Thompson, U.S. Department of Health and Human Services. "It is a top priority for the Administration to work with Congress to get a prescription drug benefit and I appreciate Abbott's support of that priority."

"Comprehensive Medicare reform with an affordable prescription drug benefit remains one of my top priorities in the 108th Congress," said Sen. John Breaux (D-La.). "I applaud Abbott's efforts to provide affordable medication options to seniors who are limited by current Medicare reimbursement. Until Medicare provides coverage for prescription drugs, programs like the Humira Medicare Assistance Program are good short-term solutions to improve access to newer treatments."

"We applaud Abbott for its successful development of Humira for the treatment of rheumatoid arthritis and the company's commitment to ensuring that Medicare recipients have access to this therapy," said Rep. Mark Kirk, (R-IL). "Abbott's commitment to provide this drug to all Medicare recipients who do not have access to any form of drug reimbursement plan is a further testament to their caring and compassionate approach until a Medicare prescription drug benefit is passed by Congress."

"As a rheumatologist, it's important to be able to make treatment decisions based on the appropriate medicine for the patient, not based on their prescription drug coverage," said Yvonne Sherrer, M.D., medical director and director of clinical research at the Center for Rheumatology, Immunology and Arthritis in Fort Lauderdale, Florida. "Abbott's Humira Medicare Assistance Program allows me to be able to have this new medicine as an option, even for patients who don't have prescription drug coverage."

In addition to the Humira Medicare Assistance Program, Abbott is offering reimbursement information support through the Humira Resource Center. Through this resource center, patients with RA can find out about their options for prescription coverage for Humira through private insurance or eligibility for federal and state assistance programs, as well as other Abbott programs.

Abbott has a Patient Assistance Program for patients in need who meet specific financial criteria to receive Humira at no cost.

Important safety information

Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation have been observed in patients receiving Humira. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including Humira. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections.

Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including Humira. TNF-blocking agents, including Humira, have been associated in rare cases with exacerbation of demyelinating disease.

The most frequent adverse events seen in the placebo-controlled clinical trials (Humira vs. placebo) were upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for Humira and 4 percent for placebo.As with any treatment program, the benefits and risks of Humira should be carefully considered before initiating therapy.

More information about Abbott Immunology and Humira, including full prescribing information, is available on the Web sites, www.abbottimmunology.com  and  www.Humira.com

Source: Abbott Laboratories

Source: Abbott Laboratories

ABBOTT PARK, ILL., Decomber,31,2002 -- Abbott Laboratories on New Year's Eve received FDA approval to market Humira (adalimumab), previously known as D2E7. Humira is the first human monoclonal antibody approved for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs).

Humira was created using phage display technology, resulting in an antibody with human-derived heavy and light chains variable regions and human IgG1:K constant regions.

"We're pleased to receive the approval of Humira earlier than anticipated," said Miles D. White, chairman and chief executive officer, Abbott Laboratories. "The approval of Humira is not only a milestone for Abbott, more importantly it is an example of the positive impact pharmaceutical innovation can have for people living with chronic and debilitating conditions like RA."

Humira will offer convenient every-other-week dosing by subcutaneous injection (shot beneath the skin). A specially designed prefilled syringe for RA patients whose hands may be affected by crippling joint destruction will be available in pharmacies in February, 2003. Abbott is confident it can supply sufficient quantities to meet patient demand and recently announced a manufacturing expansion to meet future demand for Humira, as well as other biologics in its pipeline.

The FDA's approval of Humira comes only nine months after simultaneous regulatory submissions in the United States and Europe.

Approval of Humira was based on the efficacy and safety data obtained in four controlled clinical trials in more than 2,000 RA patients. The efficacy of Humira was assessed by evaluating patients' improvement in RA signs and symptoms response scores and the inhibition of the progression of structural damage in RA as measured by bone changes in X-rays. Safety was also assessed in these trials, which included one of the largest safety trials of a TNF antagonist. In these trials some patients experienced an improvement in RA signs and symptoms as early as one week (22 percent, 14/63 patients).

American College of Rheumatology (ACR) responses have been seen in some patients out to three years. Humira is approved for use alone or in combination with traditional DMARDs. For most patients, the recommended dose of Humira is 40mg every other week by subcutaneous injection, which is more convenient than currently available medications.

"As rheumatologists, our goal in RA treatment is to treat the pain and swelling as well as slow the progression, which is why it's exciting to have a new option with Humira," said Michael Schiff, M.D., director of clinical research, Denver Arthritis Clinic, clinical professor of medicine, Rheumatology Division, University of Colorado School of Medicine and a lead investigator for Humira clinical trials. "In my experience with Humira, some patients see a rapid improvement in their signs and symptoms as early as one week, which allows them to participate in normal daily activities. Just as important is the ability of Humira to inhibit the progression of the disease, which means it slows the damage to the joints that occurs over time."

Humira resembles antibodies normally found in the body. Humira works by specifically blocking tumor necrosis factor alpha (TNF-a), a protein that plays a central role in the inflammatory responses of autoimmune diseases such as RA.

Important safety information

Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, have been observed in patients receiving Humira. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including Humira. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections.

Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including Humira. TNF-blocking agents, including Humira, have been associated in rare cases with exacerbation of demyelinating disease.

The most frequent adverse events seen in the placebo-controlled clinical trials (Humira vs. placebo) were upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for Humira and 4 percent for placebo. As with any treatment program, the benefits and risks of Humira should be carefully considered before initiating therapy.

Specially designed syringe

Humira is available in a pre-filled syringe that was specially designed for use by patients who may have limited use of their hands as a result of the destructive progression of RA. The syringe has unique plastic wings that are easy to hold and will allow those patients who are prescribed Humira in the pre-filled syringe to self-administer their Humira at home without having to mix or measure their medication. This unique design was reviewed by an independent panel of people with arthritis and health professionals and received the Arthritis Foundation Ease of Use Commendation Seal.

The European Agency for the Evaluation of Medicinal Products (EMEA) accepted Abbott's submission for Humira for the treatment of RA in April 2002, and approval is anticipated in mid-2003.

About RA

More than five million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of hands, feet and wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, resulting in eventual destruction of the joint's interior and the surrounding bone.

The long-term prognosis for patients with RA is poor, and as a result, many patients face increased disability and premature death.

Patients interested in more information about RA can visit the Web site, www.RA.com

More information about Abbott Immunology and Humira, including full prescribing information, is available on the Web sites, www.abbottimmunology.com  and  www.Humira.com

Source: Abbott Laboratories

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Posted: June 2003


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