Takeda has also received some good news from the US Food and Drug Administration advisory committee meeting on Avandia as data aired there revealed that patients taking the Japanese firm’s rival treatment Actos were less likely to suffer less cardiovascular risk than patients on GlaxoSmithKline's drug.
In putting the case for a withdrawal from the US market of Avandia (rosiglitazone), FDA officials Gerald Dal Pan and David Graham referred to data on a head-to-head comparison of the drug with another thiazolidinedione, namely Actos (pioglitazone). The results showed that patients on the latter had 22% fewer heart attacks than those using Avandia, according to the review of nearly 30,000 diabetics treated from 2003 to 2006.
In the study, 161 of 14,807 patients taking Actos had a heart attack, compared with 214 of 15,104 patients on Avandia. When both heart attacks and procedures done to restore blood flow were counted, there were 386 using the Takeda drug compared with 468 on GSK’s treatment.
Takeda noted that the findings are consistent with the placebo- controlled Proactive study, a prospective, randomised, placebo-controlled outcomes trial. It included 5,238 patients with type 2 diabetes and a history of macrovascular disease, who were force titrated up to 45mg daily of either Actos or placebo. The firm said that in this study, “there was no difference in the number of macrovascular events between standard of care and Actos, and standard of care alone”.
Mehmood Khan, president of Takeda Global R&D, said that “breadth and depth of Actos data – encompassing more than 16,000 patients over the past 10 years – is consistent and short- and long-term studies, and all of these have shown no evidence that the drug is associated with an increased risk of heart attack or stroke. He added that “the only scientific way to determine a medication’s safety is a prospective, long-term trial”, noting that “although drugs may be in the same class, they also can have different clinical effects due to differences in molecular structure.
Takeda profits up as Actos shines
That Takeda has benefited from GSK’s woes with Avandia has become even clearer as the Japanese firm has just posted a 5.1% increase in net income for the three months ended June 30 to 131 billion yen (around $1.1 billion). Sales were up 9.6% to 366.3 billion yen, and Actos brought in 106.6 billion yen, a rise of 27% on the like, year-earlier period.
Of its other products, blood pressure drug Blopress (candesartan cilexetil) reached 55.4 billion yen, an increase of 5.9%, the gastrointestinal drug Takepron (lansoprazole) inched up 1.7% to 40.8 billion yen, and turnover from the prostate cancer treatment Leuplin (leuprorelin) rose 3.3% to 33.8 billion yen.