CHMP approves Infliximab for the treatment of moderate to severe plaque psoriasis
Aug 1, 2005 - 11:19:38 PM
Centocor BV and Schering-Plough Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending the approval of an expanded indication for REMICADE (infliximab). The expanded indication would include treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or psoralen plus ultraviolet light A (PUVA).
The most common form of psoriasis, plaque psoriasis is a chronic, immune-mediated disease, which results when skin cells over-produce and accumulate, causing red, scaly plaques that may itch and bleed. These symptoms can cause extreme physical discomfort and have a great impact on a person's quality of life.
The CHMP recommendation is an important step towards a European Commission approval. A Commission approval of the application will result in Marketing Authorization with unified labeling that will be valid in all EU-member states, including the current 25 member states as well as Iceland and Norway.
The positive opinion for REMICADE for psoriasis is primarily based on data from the SPIRIT (Study of Psoriasis with Infliximab Induction Therapy) and EXPRESS (European Infliximab for Psoriasis Efficacy and Safety Study) trials. Both SPIRIT and EXPRESS were multicenter, randomized, double-blind studies that assessed the efficacy of REMICADE in patients with plaque psoriasis with a Body Surface Area (BSA) of ¡¯ 10 percent and Psoriasis Area and Severity Index (PASI) score ¡¯ 12. The primary endpoint in both studies was the percent of patients who achieved ¡¯ 75 percent improvement in PASI from baseline at week 10.
Schering-Plough markets REMICADE in all countries outside of the United States, except in Japan, China and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product. Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the United States.
Psoriasis is a chronic, immune-mediated disease caused when skin cells over-produce and accumulate on the surface causing red, scaly plaques that may itch and bleed. This chronic inflammation is driven by tumor necrosis factor alpha, or TNF-alpha, a cytokine involved in the body's normal immune response. TNF-alpha is found at increased levels in psoriatic plaques and plays a crucial part in their formation and continued existence. In Europe, psoriasis affects between 1-5 percent of the population.
Psoriasis can have a great impact on a person's quality of life. The itchiness, redness, sores and flaking, can cause extreme physical discomfort. Depending on the area of the body, it can also lead to problems in intimate relationships and may result in severe depression.
REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the European Union (EU) and Japan. In the EU and in the U.S., REMICADE is approved for the treatment of active ankylosing spondylitis (AS) and psoriatic arthritis.
In the EU, REMICADE is indicated for the treatment of severe, active CD in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. REMICADE also is indicated for the treatment of fistulizing, active CD in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
For RA patients in the EU, REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate, and in patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.
In the EU, REMICADE is also indicated for treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
In addition, REMICADE, in combination with methotrexate, is approved for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatic drugs.
In the U.S., REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active RA. REMICADE is the only biologic indicated for the treatment of patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE was approved for the treatment of active AS and in May 2005, REMICADE was approved for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis in the U.S.
REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA, CD, and psoriatic arthritis, REMICADE is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. In AS, REMICADE is a two-hour infusion (5 mg/kg) administered every six weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. The safety and efficacy of REMICADE have been well established in clinical trials over the past 12 years and through commercial experience with over a half a million patients treated worldwide.
Important Safety Information
Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).
There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common.
There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.
Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE. Reports of lymphoma (a type of cancer) in patients on REMICADE and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer.
Serious infusion reactions have been reported with REMICADE, including hives, difficulty breathing, and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing, and stomach pain or mild reactions to infusion such as rash or itchy skin.
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