Cimzia(R) (certolizumab pegol) Now Available for Self-Administration in Adult Patients With Moderate to Severe Crohn's Disease

UCB today announced that Cimzia(R) (certolizumab pegol), the only PEGylated anti-TNF (Tumor Necrosis Factor) approved in the U.S. for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy, is now available for self-administration in a prefilled syringe designed in partnership with OXO GOOD GRIPS(R) a company dedicated to providing innovative consumer products that make everyday life easier.

"We looked at a variety of unmet needs for Crohn's disease patients and found that many prefer a prefilled syringe when taking biologic medications," said David Robinson, vice president and general manager of UCB's Immunology Business Unit. "This newly designed, easy-to-use syringe, developed with a renowned consumer products company like OXO(R), will enable many patients to conveniently self-administer their therapy every four weeks."

The Cimzia(R) prefilled syringe, designed by UCB in partnership with OXO GOOD GRIPS(R) is available exclusively for use with Cimzia(R). The companies recognized the importance of designing a syringe and packaging components with the patient in mind to provide ease of use, comfort, control and confidence.

The new syringe provides a soft, non-slip grip on the flange which allows the patients to hold the syringe steady using various grip positions so it is easy and comfortable to use. The large and soft thumb pad on the plunger makes it easy to push for patients. The rounded finger loop allows for easy removal of the needle cover. The easy-to-read syringe barrel helps to ensure patients receive the entire dose as they can see the medicine inside and know when they have injected all of the medication. Additionally, the packaging utilizes Velcro(R) for easy opening and resealing.

In addition, the new Cimzia(R) prefilled syringe carries the Arthritis Foundation(R) Ease-of-Use Commendation. The Arthritis Foundation(R) created the program to encourage manufacturers to design user-friendly products and packaging. Manufacturers submit their products for testing by an independent lab experienced in the design and evaluation of products that are accessible to people with functional limitations due to the effects of arthritis.

Cimzia(R) was approved by the U.S. Food and Drug Administration on April 22, 2008 for reducing the signs and symptoms of moderate to severe Crohn's disease and maintaining clinical response in adult patients who have had an inadequate response to conventional therapy. The new prefilled syringe is now available to Crohn's patients taking Cimzia(R) for subcutaneous self-administration once every four weeks after initial doses once a physician has provided instruction for proper use.

The Crohn's approval was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn's disease. Cimzia(R) was also recently approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis.

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FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

FDA today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information, or labeling.

“Under the FDA's new authorities, we can require safety label changes and a risk evaluation and mitigation strategy, known as REMS, when the agency becomes aware of new safety information,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research. “Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks.”

Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.

Patients taking TNF blockers should be aware that they are more susceptible to serious fungal infections. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention. To assist in the diagnosis, those being treated with TNF blockers should tell their health care professionals where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover.

FDA has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the Medication Guides to the FDA within 30 days or to provide a reason why they do not believe labeling changes are necessary.

If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

Medication Guides will become part of a REMS for Humira and Remicade and are already part of a REMS for Enbrel and Cimzia. The manufacturers for all four of these drugs will also be required to educate prescribers about the risks.

For more information: http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm

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Studies Highlight MRSA Evolution and Resilience

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infections are caused primarily by a single strain — USA300 — of an evolving bacterium that has spread with "extraordinary transmissibility" throughout the United States during the past five years, according to a new study led by National Institutes of Health (NIH) scientists. CA-MRSA, an emerging public health concern, typically causes readily treatable soft-tissue infections such as boils, but also can lead to life-threatening conditions that are difficult to treat.

The study, from the National Institute of Allergy and Infectious Diseases (NIAID) of NIH, resolves debate about the molecular evolution of CA-MRSA in the United States. The findings rule out the previously held possibility that multiple strains of USA300, the most troublesome type of CA-MRSA in the United States, emerged randomly with similar characteristics. The study also offers a hypothesis for the origin of previous S. aureus outbreaks, such as those caused by penicillin-resistant strains in the 1950s and 1960s.

A second study led by the same NIAID scientists takes the issue of the evolution of MRSA a step further, revealing new information about how MRSA bacteria in general, including the USA300 group, elude the human immune system.

The first study, which appears online this week in the Proceedings of the National Academy of Sciences, found that the USA300 group of CA-MRSA strains, collectively called the epidemic strain, comprises nearly identical clones that have emerged from a single bacterial strain. It is the first time scientists have used comparative genome sequencing to reveal the origins of epidemic CA-MRSA. Frank R. DeLeo, Ph.D., at NIAID's Rocky Mountain Laboratories (RML) in Hamilton, Mont., led the research.

"Scientists are pressing ahead quickly to learn more about how some MRSA strains evade the immune system and spread rapidly," says NIAID Director Anthony S. Fauci, M.D. "The information presented in these two studies adds important new insights to that expanding knowledge base."

To understand how CA-MRSA is evolving in complexity and spreading geographically, Dr. DeLeo's group sequenced the genomes of 10 patient samples of the USA300 bacterium recovered from individuals treated at different U.S. locations between 2002 and 2005. They then compared these genomes to each other and to a baseline USA300 strain used in earlier studies. Eight of the 10 USA300 patient samples were found to have nearly indistinguishable genomes, indicating they originated from a common strain. The remaining two bacteria were related to the other eight, but more distantly.

Interestingly, of the eight nearly indistinguishable USA300 patient samples, two caused far fewer deaths in laboratory mice than the others, highlighting an emerging view that tiny genetic changes among evolving strains can profoundly affect disease severity and the potential for drug resistance to develop.

"The USA300 group of strains appears to have extraordinary transmissibility and fitness," says Dr. DeLeo. "We anticipate that new USA300 derivatives will emerge within the next several years and that these strains will have a wide range of disease-causing potential." Ultimately, Dr. DeLeo and his colleagues hope that the work will lead to the development of new diagnostic tests that can quickly identify specific strains of MRSA.

Fred C. Tenover, Ph.D., of the Centers for Disease Control and Prevention in Atlanta (CDC) contributed the 10 USA300 clinical isolates from CDC's Active Bacterial Core Surveillance system. Other study collaborators included Barry N. Kreiswirth, Ph.D., of the International Center for Public Health (ICPH) in Newark, N.J., and James M. Musser, M.D., Ph.D., of The Methodist Hospital Research Institute in Houston.

The second report, which involved scientists from RML, ICPH and Vanderbilt University Medical Center in Nashville, was recently published online in the Journal of Immunology. This study provides scientists with new details about the complex mechanisms MRSA uses to avoid destruction by neutrophils, human white blood cells that ingest and destroy microbes. When exposed to hydrogen peroxide, hypochlorous acid (the active component of household bleach) or antimicrobial proteins — all killer chemicals released by neutrophils — MRSA senses danger, escapes harm and turns the tables on the white blood cells, destroying them. Work is continuing in Dr. DeLeo's lab to understand how the bacterium senses and survives attacks by neutrophils.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease

Drug currently approved for use in treating some forms of multiple sclerosis

The U.S. Food and Drug Administration has approved Tysabri (natalizumab) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies. Crohn's disease patients using the drug must be enrolled in a special restricted distribution program called the Crohn's Disease–Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program.

The approval is consistent with an agency advisory committee recommendation to approve Tysabri for use in Crohn's patients. Tysabri was approved by the FDA in June 2006 to treat relapsing forms of multiple sclerosis.

Crohn's disease is a chronic, inflammatory bowel disease that affects both men and women. There is no cure. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. The disease also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. Its cause is unknown. There are more than 1 million people with Crohn's disease worldwide.
"The addition of Tysabri to the treatment options for sufferers of Crohn's disease is important, but one that carries serious risks," said Daniel Shames, deputy director of the Office for Drug Evaluation III and director of the Division of Gastroenterology Products for the Center for Drug Evaluation and Research. "Health care providers must carefully monitor patients for these risks. The CD-TOUCH Prescribing Program will aid FDA in monitoring this drug through its life cycle."

Tysabri carries a boxed warning for progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection that affects the brain and can lead to death or severe disability.
Other serious adverse events that have occurred in Tysabri-treated patients include hypersensitivity reactions, such as anaphylaxis and liver injury. Serious opportunistic and other atypical infections have been observed in patients receiving immunosuppressants while on Tysabri, and Tysabri should generally not be used in patients receiving immunosuppressants. Serious herpes infections have also been observed. Common side effects include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.

Because of these risks, patients, prescribers, pharmacies, and infusion centers must all be enrolled in CD-TOUCH and agree to comply with the company's strict monitoring guidelines. Additionally, they must participate in an extensive educational program designed to inform people about the risks of Tysabri treatment. Tysabri is administered intravenously by trained professionals at infusion centers.


Under CD-TOUCH, health care providers evaluate Crohn's disease patients after three months of treatment to determine if they have improved on Tysabri. If not, patients should discontinue treatment. People who are taking steroids for Crohn's disease should begin tapering steroid doses while on Tysabri. Treatment should be discontinued if steroids cannot be fully tapered within six months.

Tysabri is manufactured by Biogen Idec of Cambridge, Massachusetts and Elan of Dublin, Ireland. Both companies have agreed to conduct long-term surveillance for safety, including monitoring and expedited reporting of PML infections, other serious opportunistic infections, malignancies, and deaths in people treated with Tysabri.

For more information on Crohn's Disease, visit:

Crohn's Disease–National Institute of Diabetes and Digestive and Kidney Diseases www.digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.htm