September will prove a testing time for Bristol-Myers Squibb, which will see two of its big hopes up before US Food and Drug Administration advisory panels.
First up is Orencia (abatacept), its new therapy for rheumatoid arthritis, which is designed to take a hefty bite out of the market for TNF-inhibitors, including Wyeth and Amgen’s multi-billion dollar drug Enbrel (etanercept). Orencia is a selective T-cell co-stimulation modulator, but will be put under the spotlight to assess its rate of serious infections, a side effect associated with most biological arthritis agents. This concern appears to have been backed up by recent data from the Phase III ASSURE study, which showed a higher incidence of serious infections for Orencia versus placebo.
Following completion of its rolling submission in March, B-MS has requested a priority review, which means the drug could be approved by the end of September.
Meanwhile, three days later, B-MS’ diabetes agent Pargluva (muraglitazar) faces its destiny when it comes before the advisory committee. If approved, Pargluva will become the first-ever dual peroxisome proliferators-activator agonist, a class of drugs that have had a level of skepticism directed at them. In one 24-week, Phase III study, involving 1,160 type 2 diabetes patients, Pargluva was linked to a significant reduction in blood glucose levels versus Lilly/Takeda’s Actos (\\\rosiglitazone). However, oedema rates were 9.2% amongst Pargluva receivers, compared to 7.2% in the Actos group, while three cases of heart failure were observed versus one amongst patients given the Lilly/Takeda drug. In the Phase II trial, 15 cases of heart failure were reported in the Pargluva arm with none in the Actos arm.