NEWS - FDA committee backs abatacept in unanimous vote

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FDA committee backs abatacept in unanimous vote

Rheumawire

Sep 7, 2005

Gandey

Rockville, MD - Amid a flurry of speculation about how the US Food and Drug

Administration arthritis drugs advisory committee would respond to

increasing concerns over safety, the panel gave Bristol-Myers Squibb's new

T-cell costimulator abatacept (Orencia) a solid vote of confidence in favor

of fast-tracking the product through regulatory approval. If the FDA acts on

the committee's decision, abatacept could be approved in the US before the

end of the year. But despite the unanimous support of the committee,

panelists raised several concerns about the product's use in vulnerable

populations.

Abatacept has been proposed as an alternative for patients with moderate or

severe rheumatoid arthritis (RA) who have had an inadequate response to one

or more disease-modifying antirheumatic drugs (DMARDs) or TNF blockers. But

the product has also been linked to a spike in serious infections

particularly when used in combination with other biologics. During

his presentation to the committee, Dr s, senior vice president

of global clinical development for Bristol-Myers Squibb, acknowledged the

problem and advised that abatacept not be used with background biologics.

Meeting participant and editorial consultant for www.jointandbone.org Dr

Felson (Boston University School of Medicine, MA) questioned the

safety of abatacept in very young and elderly populations. " I want to raise

a concern about the high rate of infection in vulnerable people given this

therapy and anti-TNF therapy. The studies really didn't look at the very

young or old so we're really not going to know, " Felson said during a

group-discussion period. He also added that at this point he wouldn't take a

chance by suggesting this product for pregnant women when so many other

alternatives are available.

Meeting chair Dr Allan Gibofsky (Cornell University, Ithaca, NY) said that

he agreed and referred to his own apprehension as " a natural queasiness. " He

explained, " There is great concern over the extent to which we can

extrapolate clinical-trial data to clinical practice. And that concern

increases when looking in clinical practice at people who did not even meet

the trial criteria. "

The committee evaluated data from three randomized, placebo-controlled

studies of abatacept in RA patients that looked at the proposed

weight-tiered dosing regimen and two other studies that assessed a regimen

of 10 mg/kg. One study focused on monotherapy with abatacept, and the four

others looked at the product used as add-on therapy.

Abatacept first in class?

The committee widely supported the product's efficacy. " I think it works, "

Felson told the panel. Dr Finley (Western University College of

Osteopathic Medicine, Pomona, CA) called abatacept the first of a " new

class " of drugs. Patient representative Leona Malone from Palm Beach

Gardens, FL concurred with the committee but asked that patients be informed

about the potential risks of abatacept so that they can make informed

decisions in consultation with their doctors.

Dr Janet Elashoff, director of biostatistics at Cedars-Sinai Medical Center

(Los Angeles, CA), raised a number of concerns about the studies. She

pointed to the volume of data coming from countries outside the US and asked

the FDA about its policies on this practice. Elashoff was told that there

are currently no specific guidelines concerning region of study and that

data from various countries are frequently generalized to the US. Elashoff

also critiqued the radiographic data presented by Bristol-Myers Squibb. She

considered it inadequate and suggested that these data represent an

exception where efficacy was not established. But despite these drawbacks,

Elashoff voted in accordance with her colleagues and said that the risk

associated with abatacept " seems consistent with other drugs. "

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org