ORENCIA (Abatacept) Supplemental Biologics License Application For Juvenile Idiopathic Arthritis Accepted By FDA For Filing & Review

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ORENCIA (Abatacept) Supplemental Biologics License Application For Juvenile

Idiopathic Arthritis Accepted By FDA For Filing And Review

http://www.medicalnewstoday.com/articles/79123.php

Article Date: 09 Aug 2007 - 1:00 PDT

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and

Drug Administration (FDA) has accepted, for filing and review, the

supplemental biologics license application (sBLA) for ORENCIA (abatacept)

for the treatment of pediatric patients with juvenile idiopathic arthritis

(JIA) who have had an inadequate response to one or more disease-modifying

anti-rheumatic drugs (DMARDs) such as methotrexate (MTX) or tumor necrosis

factor (TNF) antagonists.

This sBLA is based on data from a double-blind, randomized trial that

consisted of three periods: a four-month open-label lead-in treatment period

in which all participants (6-17 years old) received ORENCIA and both

clinical response and safety were assessed (Period A), a six-month

randomized double-blind withdrawal phase in which responders received either

ORENCIA or placebo and time to disease flare and safety were assessed

(Period , and an open-label phase in which all participants received

ORENCIA in order to assess long-term efficacy and safety (Period C).

ORENCIA, which was discovered and developed by Bristol-Myers Squibb, is

currently approved for use in adults with moderate to severe rheumatoid

arthritis (RA) who have had an inadequate response to one or more DMARDs

such as MTX or TNF antagonists. ORENCIA is a selective modulator of a

costimulatory signal required for full T-cell activation.

About Juvenile Idiopathic Arthritis

JIA - also commonly known as juvenile rheumatoid arthritis (JRA) - is a

chronic, autoimmune disease, causing chronic pain, stiffness and swelling of

the joints, which may ultimately lead to joint damage and deformities. The

disease usually begins before the age of 16 and may affect up to 1 child in

every 1,000 in the United States.

Important Safety Information about ORENCIA (abatacept)

Before receiving treatment with ORENCIA individuals should tell their doctor

if they are taking a TNF blocker (e.g., Enbrel, Humira, Remicade) to treat

rheumatoid arthritis (RA). ORENCIA should not be taken with these

medications because of a higher chance of getting a serious infection.

Individuals should also tell their doctor if they are taking Kineret to

treat RA. ORENCIA should not be taken with Kineret. People taking ORENCIA

should notify their doctor if they are taking any other medications

including hormones, over-the-counter medicines, vitamins, supplements or

herbal products.

Individuals should let their doctor know if they have any kind of infection

including an infection that is in only one place of the body (such as an

open cut or sore) or an infection that is in the whole body (such as the

flu). Having an infection could increase the risk for serious side effects

from ORENCIA. It is also important for individuals to let their doctor know

if they have an infection that won't go away or a history of infections that

keep coming back.

People who have had tuberculosis (TB), a positive skin test for TB, recent

close contact with someone who has had TB or develop any of the symptoms of

TB (a dry cough that doesn't go away, weight loss, fever, night sweats)

should call their doctor right away. Before starting treatment with ORENCIA,

a doctor may examine the individual for TB or perform a skin test.

In addition, individuals should let their doctor know if they are scheduled

to have surgery or any vaccination or have recently received a vaccination.

People should inform their doctor if they have a history of chronic

obstructive pulmonary (lung) disease (COPD). Taking ORENCIA may cause COPD

symptoms to get worse.

People who have diabetes and use a blood glucose monitor to check their

sugar levels should tell their doctor. The infusion of ORENCIA contains

maltose, a sugar that can give falsely high blood glucose readings with some

monitors on the day the infusion is received. The doctor may recommend a

different monitor.

Women who are pregnant, planning to become pregnant or are thinking about

becoming pregnant should tell their doctor. It is not known if ORENCIA

(abatacept) can harm an unborn baby. Women who are breast feeding should

also inform their doctor. They will need to decide to either breast-feed or

receive treatment with ORENCIA, but not both.

Important Information about Side Effects with ORENCIA

Like all medicines that affect your immune system, ORENCIA can cause serious

side effects. The possible serious side effects include serious infections

and allergic reactions. Also, rare cases of certain kinds of cancers have

been reported.

People taking ORENCIA are at increased risk for developing infections

including pneumonia, and other infections caused by viruses, bacteria, or

fungi. Individuals should call their doctor immediately if they feel sick or

get any infection during treatment with ORENCIA.

Allergic reactions are usually mild or moderate, generally occur within the

first 24 hours of an infusion, and include hives, swollen face, eyelids,

lips, tongue, throat, or trouble breathing. There have been some serious

allergic reactions reported after receiving an infusion of ORENCIA.

There have been rare cases of certain kinds of cancer. The role of ORENCIA

in the development of cancer is not known.

The more common side effects with ORENCIA are headache, upper respiratory

tract infection, sore throat, and nausea.

For Full Prescribing Information, please visit www.ORENCIA.com or

www.bms.com

Dosing and Administration

ORENCIA is administered by a healthcare professional as a 30-minute

intravenous infusion at a fixed dose based on body weight range

approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks

thereafter. Acute infusion-related reactions were experienced in nine

percent of people treated with ORENCIA and in six percent of people treated

with placebo. According to the full prescribing information, the most

frequently reported infusion-related adverse events (1 percent to 2 percent)

were dizziness, headache, and hypertension. In pivotal studies,

premedications were not required. However, appropriate medical support

measures for the treatment of hypersensitivity reactions should be available

for immediate use in the event of a reaction.

About ORENCIA (abatacept)

ORENCIA is currently indicated in the United States for reducing signs and

symptoms, inducing major clinical response, inhibiting the progression of

structural damage, and improving physical function in adults with moderately

to severely active rheumatoid arthritis who have had an inadequate response

to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may

be used as monotherapy or concomitantly with DMARDs other than TNF

antagonists. ORENCIA should not be administered concomitantly with TNF

antagonists and is not recommended for use concomitantly with anakinra.

Bristol-Myers Squibb Company is a global pharmaceutical and related health

care products company whose mission is to extend and enhance human life.