Lilly’s Prasugrel Denied FDA Priority Review?
Make a commentBy Ed Silverman // February 11th, 2008 // 4:25 pm
That’s the interpretation from Tim Anderson, a securities analyst at Sanford Bernstein, who notes that the drugmaker hasn’t crowed about receiving a 6-month priority review, even though last Friday was the date by which the agency would have conveyed its decision. In an investor note today, Anderson writes that Lilly filed its request on Dec. 26 and, as a result, the blood thinner will likely receive the standard 10-month review instead.
” To us it increasingly looks like the product may not get a 6-month “priority review” by FDA,” writes Anderson. “The date by which Lilly would have likely learned of FDA’s decision appears to have been around last Friday. While an ‘official’ letter may not go out to Lilly until sometime later, our understanding is that the company would generally know at the 45-day mark (i.e. last Friday) if priority review status had been awarded. The lack of news…implies that prasugrel was NOT (his emphasis) awarded this.
“If true, this would be a small negative,” he continues. However, “not getting priority review status raises the possibility that the FDA has outstanding concerns with prasugrel.” We have sought comment from Lilly and will update if, or when, a reply is received.
You may recall that, two months ago, Lilly released a study found that prasugrel can lower the risk of cardiovascular death, non-fatal heart attacks or non-fatal strokes when compared with Plavix. But the med caused some patients to experience a statistically significant increase in major bleeding compared to those treated with Plavix, the $7 billion gorilla of blood thinners. Overall, for every 1,000 people treated with prasugrel compared to Plavix, there were 23 fewer heart attacks and an additional six major bleeding complications.
Anderson adds that the FDA could review the drug at an advisory committee meeting in either June or August, making it still less likely a final FDA decision would be completed by then. “In our view, prasugrel’s ‘approvability’ – or perhaps better stated, the timing of approvability – remains questionable,” writes Anderson, who forecasts about $950 million in sales for the drug in 2012, a figure he calls ‘modest.’