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FDA Approves Humira

FDA Approves Humira (adalimumab) for Rheumatoid Arthritis

Abbott Park, Illinois, December 31, 2002 — Abbott Laboratories received U.S. Food and Drug Administration (FDA) approval to market Humira™ (pronounced Hū-'mare-ah) (adalimumab) (pronounced ā-da-'lim-yoo-mab), 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 next month. 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.

Clinical Data Supporting Humira Approval

The 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, including 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.

"Humira represents Abbott's commitment to finding innovative and convenient solutions for patients by offering a new biologic treatment that effectively slows the progression of joint destruction caused by their disease and is easy for RA patients to use," said Jeff Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, Abbott Laboratories. "The approval of Humira is the latest advance in the evolution of monoclonal antibodies and a result of outstanding commitment from more than 300 Abbott scientists."

Specially Designed Syringe for Humira

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.

About Humira

Humira was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team would discover human antibody therapeutics. Humira was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to Humira, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for Humira, and CAT will receive a royalty fee based on Humira sales.

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.

Abbott's Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. Founded in 1989, the Abbott Bioresearch Center in Worcester, Mass., is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.

Abbott announced the Access to Therapy (ACT) study in early October to allow eligible patients who had failed treatment with at least one traditional DMARD, and who were in need of another treatment option, to access Humira until it received FDA approval. Abbott is also working with other regulatory agencies in countries around the world to initiate similar programs. Based on local regulatory requirements, study design and protocol may differ. Currently, Humira has been made available via patient named basis programs or study protocols in Europe.

Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries.

Abbott will webcast its live conference call regarding today's news through its Investor Relations Web site at www.abbottinvestor.com at 9 a.m., Central time, on Thursday, January 2, 2003. An archived edition of the call will be available after 11 a.m. Central time, on Thursday, January 2, 2003.

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

Posted: December 2002

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