New RA Med just FDA Approved????

[Guest guest]

Hi guys.

I have been on Remicade since May and it has stopped working. I thought I

was having a flare but my wrist has been swollen to the point of being

unable to use for over two months now. My doc has upped my infusions to

every 4 weeks at the max dosage instead of every 8 weeks. It hasnt helped.

So he says there is a new medicine coming out this month- just being

approved by the FDA. Its on the same level as Remicade but he didnt tell me

the name of it. Has anyone heard anything about it?

Jill

[Guest guest]

This may be it:

" Posted : 12/24/2005 6:45 PM

PRINCETON, NEW JERSEY (December 23, 2005) -- Bristol-Myers Squibb

Company (NYSE: BMY) announced today that the U.S. Food and Drug

Administration (FDA) has approved Orencia® (abatacept), the first

selective modulator of a co-stimulatory signal required for full T-

cell activation, for the treatment of rheumatoid arthritis (RA).

Orencia is indicated for reducing the signs and symptoms of RA,

inducing major clinical response, slowing the progression of

structural damage, and improving physical function in adult patients

with moderately to severely active RA 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. 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 is committed to discovering and developing

innovative medications that address areas of significant unmet

need, " said R. Dolan, chief executive officer, Bristol-Myers

Squibb. " There is clearly a need for more therapies for rheumatoid

arthritis, and Orencia has the potential to help many people with

this serious disease. Orencia is our first internally-discovered

biologic and it further diversifies our pharmaceutical portfolio. "

Orencia was studied in patients with an inadequate response to

DMARDs. Specifically, it is the first approved agent to demonstrate

efficacy and safety in patients with an inadequate response to TNF

antagonists, as well as those with an inadequate response to MTX.

Methotrexate is the most widely used non-biologic DMARD for RA and

TNF antagonists are the most widely used biologic therapies for RA.

Orencia is also the first in a new class of agents for the treatment

of RA that selectively modulates a co-stimulatory signal required

for full T-cell activation.

" In clinical trials, Orencia significantly reduced the signs and

symptoms of rheumatoid arthritis among patients who had inadequate

response to DMARDs such as methotrexate and/or anti-TNF therapy when

compared to placebo, " said Mark Genovese, M.D., associate professor

of medicine at the Stanford University School of Medicine, Palo

Alto, CA. " Rheumatoid arthritis is a very serious disease and it is

critical that we continue to add therapies to our armamentarium. "

Orencia Clinical Development Program

The efficacy and safety profiles of Orencia have been studied

through a rigorous clinical trial program that included more than

2,600 patients. More than 3,800 person-years of experience were

included across the placebo-controlled and open-label extension

periods of the clinical trials.

The Phase III trial program included three major double-blind

randomized placebo-controlled studies: AIM (Abatacept in Inadequate

responders to Methotrexate), which compared Orencia in combination

with MTX to MTX alone; ATTAIN (Abatacept Trial in Treatment of Anti-

TNF INadequate responders), which compared Orencia in combination

with non-biologic DMARDs to non-biologic DMARDs alone in patients

with an inadequate efficacy response to the TNF antagonists

etanercept and infliximab; and ASSURE (Abatacept Study of Safety in

Use with other RA thErapies), which studied the safety of Orencia

compared to placebo when used in combination with a variety of

biologic and non-biologic DMARDs.

In both pivotal Phase III efficacy studies (AIM and ATTAIN), Orencia

demonstrated significant and sustained improvement of the signs and

symptoms of RA as measured by American College of Rheumatology (ACR)

20, 50, and 70 scores, with significant difference from placebo by

day 15 for ACR 20 in some patients, which was the first follow-up

visit after the first dose. In both trials, significant improvements

in physical function were noted as compared to placebo. Health-

related quality of life was assessed by the SF-36 questionnaire;

improvements were observed in the patients treated with Orencia as

compared to placebo in all eight domains* of the SF-36. ACR

responses and improvements in physical function were maintained up

to three years in a Phase II trial of patients with inadequate

response to MTX.

Additionally, a significant proportion of patients taking Orencia

plus MTX achieved a major clinical response, defined as maintaining

an ACR 70 score for six consecutive months, compared to those

treated with MTX alone in AIM (14 percent versus 2 percent; p-value

less than 0.001).

In AIM, structural damage was slowed in patients treated with

Orencia plus MTX, compared to those treated with MTX alone.

Important Safety Information about Orencia

Concurrent therapy with Orencia and a biologic DMARD is not

recommended. In controlled clinical trials, patients receiving

concomitant Orencia and TNF antagonist therapy experienced more

infections (63 percent) and serious infections (4.4 percent)

compared to patients treated with only TNF antagonists (43 percent

and 0.8 percent, respectively), without an important enhancement of

efficacy.

Caution should be exercised in patients with a history of infection

or underlying conditions which predispose them to infections.

Treatment with Orencia should be discontinued if a patient develops

a serious infection. Patients should be screened for tuberculosis

and if positive, should be treated with standard medical practice

prior to therapy with Orencia.

Less than 1 percent of patients treated with Orencia experienced

hypersensitivity reactions, including two cases of anaphylaxis or

anaphylactoid reactions. Other events potentially associated with

drug hypersensitivity, such as hypotension, urticaria, and dyspnea,

each occurred in less than 0.9 percent of patients treated with

Orencia and generally occurred within 24 hours of an infusion with

Orencia. Appropriate medical support measures for the treatment of

hypersensitivity reactions should be available.

Live vaccines should not be given concurrently with Orencia or

within three months of its discontinuation.

Chronic obstructive pulmonary disease (COPD) patients treated with

Orencia developed adverse events more frequently than those treated

with placebo, including COPD exacerbations, cough, rhonchi, and

dyspnea. Use of Orencia in patients with rheumatoid arthritis and

COPD should be undertaken with caution and such patients should be

monitored for worsening of their respiratory status.

Orencia should be used during pregnancy only if clearly needed. Rats

treated every three days with abatacept during early gestation

throughout the lactation period showed no adverse effects in the

offspring at doses up to 45 mg/kg. At a dose of 200 mg/kg,

alterations of immune function consisted of a 9-fold increase in the

T-cell dependent antibody response in female pups and inflammation

of the thyroid in one female out of 10 male and 10 female pups

evaluated. Whether these findings indicate a risk for development of

autoimmune diseases in humans exposed in utero to abatacept has not

been determined.

Nursing mothers should discuss with their healthcare practitioner

the risk/benefit of continued breast-feeding or discontinuation of

the drug.

The most serious adverse reactions were serious infections (3

percent Orencia versus 1.9 percent placebo) and malignancies (1.3

percent Orencia versus 1.1 percent placebo).

The overall frequency of malignancies was similar in patients

treated with Orencia and placebo-treated patients. However, more

cases of lung cancer were observed in patients treated with Orencia

(0.2 percent) than placebo-treated patients (0 percent). A higher

rate of lymphoma was seen compared to the general population;

however, patients with RA, particularly those with highly active

disease, are at a higher risk for the development of lymphoma. The

potential role of Orencia in the development of malignancies in

humans is unknown.

The most frequent adverse events occurring in greater than or equal

to 10 percent of patients treated with Orencia were headache, upper

respiratory tract infection, nasopharyngitis, and nausea.

Orencia Prescribing Information

Visit www.orencia.com

Dosing and Administration

Orencia (a fully human soluble fusion protein) is administered as a

30-minute intravenous infusion at a fixed dose based on weight range

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

weeks thereafter. Infusion reactions were experienced in 9 percent

of patients treated with Orencia and in 6 percent of patients

treated with placebo. The most frequently reported events (1 percent

to 2 percent) were dizziness, headache, and hypertension. In

clinical trials, 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.

Orencia Supply Information

Orencia is expected to be available for initial commercial use by

the end of February 2006. As previously stated, in order to increase

production capacity and meet expected long-term demand for Orencia,

Bristol-Myers Squibb expects to submit a supplemental biologics

license application (sBLA) to the FDA for a third-party

manufacturing facility shortly. During this period between BLA and

sBLA approval, a single distributor will be used. For more

information, healthcare providers and patients can call 1-800-

ORENCIA (673-6242) or visit www.orencia.com.

Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune disease

characterized by inflammation in the lining of joints (or synovium),

causing joint damage with chronic pain, stiffness, and swelling1. RA

causes limited range of motion and decreased function as a result of

affected joints losing their shape and alignment.1

RA affects about 1 percent of the world's population2, including

more than two million people in the United States3. The condition is

more common in women than in men, who account for 75 percent of

patients diagnosed with RA.3

Bristol-Myers Squibb is a global pharmaceutical and related health

care products company whose mission is to extend and enhance human

life. "

There is another new drug in the final stages of approval, it is

called Rituximab (Rituxan). That is the one I am trying today, (in

two hours!), it blocks B-Cells, so it is a little different than the

TNF blockers like Abacept, Humira, Enbrel, and Remicade.

Hope that helps!

Melisa