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New RA drug from BMS gains recommendation

Published on 07/09/05 at 05:46pm

A new treatment for rheumatoid arthritis from Bristol-Myers Squibb has received recommendation approval from an FDA committee, bringing it one step closer to approval.

The arthritis committee has unanimously recommended Orencia (abatacept) the first in a new class of drugs called selective modulators of T-cell co-stimulation which could be a major advance in the treatment of rheumatoid arthritis (RA).

T-cell activation plays an important role in activating the autoimmune response seen in RA sufferers, and phase III trials showed the drug helped patients who failed to respond to standard treatment methotrexate.

Three drugs in the TNF-blocker class of drugs currently represent the cutting edge of treatment - Johnson & Johnson's Remicade, Wyeth/Amgen's Enbrel and Abbott's Humira.

These drugs block the action of Tumour Necrosis Factor (TNF) a protein that destroys tumour cells but can also attack healthy cells, as in rheumatoid arthritis.

Orenica works by blocking the autoimmune response a stage earlier, by stopping the co-stimulation of T-cells, which in turn produce TNF.

One early trial showed patients who had failed to respond to the TNF-blockers showed signs of improvement when taking Orenica in conjunction with one or more older disease-modifying drugs. The evidence suggested the drug had the potential to eclipse the TNF-blocker class, although two are already blockbusters, with Humira expected to exceed $1billion in sales this year.

The FDA said it will need up to three months to complete the review of Orenica because of the complex manufacturing process needed to produce the drug.

Anticipating manufacturing delays, BMS has already filed to open a second manufacturing facility once the drug is approved, and indicated its launch could be delayed because of this.

Like the TNF-blockers, trials of the drug has shown high rates of serious infections compared to placebo, and this adverse effect could prove to be the company's biggest obstacle.

BMS has already presented its proposed pharmacovigilance programme to the FDA along with its pre-clinical and clinical data.

Related articles:

Humira receives two European recommendations 

Friday , July 01, 2005

 

 

 

 

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