Two new RA drugs on the horizon

[Guest guest]

Two new RA drugs on the horizon



Sep 2, 2005



Gandey

Rockville, MD - This week Genentech, Biogen, and Roche, the makers of

rituximab, announced that they have applied to the US Food and Drug

Administration for a new indication for the treatment of rheumatoid

arthritis (RA). And next week, the FDA's arthritis drug advisory

committee will evaluate abatacept (Orencia, Bristol-Myers Squibb) for

the treatment of moderately to severely active RA. An FDA

spokesperson declined rheumawire's request for comment about

rituximab, but on the subject of abatacept, Mahoney, from the

agency's Center for Drug Evaluation and Research, said the product is

a " new molecular entity, " and it is common for questions surrounding

such developments to be brought before a committee. The two

submissions could have important implications for RA patients

especially those who respond inadequately to anti-TNF therapy.

" Rituximab may provide a potential new treatment approach for the RA

patient population with the greatest unmet medical need, " Dr Hal

Barron, Genentech's senior vice president, development, and chief

medical officer said in a statement to the press. " This submission

marks an important milestone in our ongoing efforts to develop novel

therapies for B-cell-mediated diseases. "

Rituximab is said to target and selectively deplete CD20+ B cells

without targeting stem cells or existing plasma cells. Marketed under

the brand names Rituxan and MabThera, the product is currently

available for the treatment of indolent non-Hodgkin's lymphoma.

According to the companies, it is also being investigated in other

autoimmune diseases such as lupus, multiple sclerosis, and ANCA-

associated vasculitis.

Armed with new 24-week results of a multicenter, randomized, double-

blind, placebo-controlled phase 3 study, the manufacturers have shown

that patients who received a single course of two infusions of

rituximab with a stable dose of methotrexate had a statistically

significant improvement in symptoms compared with those who received

placebo and methotrexate. The study, known as the Randomized

Evaluation of Long-term Efficacy of Rituximab in RA (REFLEX), is

ongoing, and new results are anticipated to be presented in November

at the American College of Rheumatology meeting in San Diego, CA.

The most common reported side effects of rituximab include headache,

upper-respiratory-tract infection, and nasopharyngitis. The

investigators say that the rate of serious adverse events has been

comparable across treatment arms.

FDA committee to evaluate abatacept

On Tuesday, September 6, Bristol-Myers Squibb will present data on

its selective T-cell costimulation modulator abatacept. The company

has requested a priority review, which means the biologic could be

approved as early as the end of September.

Bristol-Myers Squibb is expected to base much of the case for its

product on the phase 3 trial data recently presented at the European

League Against Rheumatism (EULAR) meeting. The trial, known as the

Abatacept Study of Safety in Use with Other Rheumatoid Arthritis

Therapies (ASSURE) and the largest to date for the product, showed a

favorable safety profile for abatacept when used in combination with

standard disease-modifying antirheumatic drugs (DMARDs). But as

previously reported by rheumawire, among the safety concerns are the

product's rate of serious infectionsparticularly when used in

combination with other biologics.

Speaking about the trial at EULAR, lead author and presenter Dr

Weinblatt (Brigham and Women's Hospital, Boston, MA), told

rheumawire at the time, " My interpretation is that abatacept should

not be used with a background biologic. " But he said that, overall,

he considers the safety profile of abatacept " very acceptable " and

" reassuring. "

www.jointandbone.org will be covering the FDA meeting evaluating

abatacept and will report on the committee's findings. Already, the

FDA has asked Bristol-Myers Squibb to refrain from pursuing any

direct-to-consumer advertising for a minimum of 12 months following

the launch of any new medications. On September 9, a separate

committee will review the company's diabetes drug muraglitazar

(Pargluva).

http://www.jointandbone.org/viewArticle.do?primaryKey=552071