Woodcock: FDA wary of Vytorin debate

Expect the FDA to stay out of the Vytorin fray, at least for now. So Janet Woodcock (photo), CDER chief, told FDAWeb in an interview (recounted, in turn, by Pharmalot). The agency is afraid of seeming "defensive" if it weighs in now. But Woodcock did make clear that FDA still considers lowering "bad" cholesterol--which Vytorin did quite well in the Enhance study--to be a valid surrogate for heart-disease prevention.

Scientific nitpicking about LDL is misleading people, Woodcock said: "[T]here is some little point that the scientists are arguing about, and then the media get on it, and they start throwing the baby out with the bathwater," she said. "...[but if] people think we're just being defensive, we wouldn't make a difference in this environment."

Meanwhile, new data is in on the expected drop-off in Vytorin and Zetia scrips. A Deutsche Bank analyst surveyed primary care docs and found that 75 percent expect usage of both drugs will drop in their practices. The analyst now predicts that market share for Vytorin will drop to 9 percent from 16 percent. Zetia, one of the drugs in the Vytorin combo, will see its share drop to 6 percent from 9.5 percent, the analyst concluded.

Some of that drop-off will be in new scrips, some from patients switching. In an investor note, the analyst predicted "increased utilization of other statins, especially [Pfizer's] Crestor."

- see the Woodcock interview excerpt at Pharmalot
- check out the scrip numbers
- see Pharmalot's analysis of Deutsche Bank's predictions

Related Articles:
FDA's Woodcock handed back the reins at CDER
FDA chief: Woodcock is a 'change agent'
UnitedHealth stands by Vytorin
Insurers, PBMs mull Vytorin data.
Congress: Merck, Schering-Plough sat on bad news
ACC panel unleashes Vytorin whirlwind

Suggested Articles

Eli Lilly and Incyte are investing heavily in JAK inhibitor Olumiant's chances in atopic dermatitis, but does it stand a chance against Dupixent?

Krystal Biotech has started on a new manufacturing facility for eventual commercial supply of gene therapies in its pipeline.

Chinese authorities have recommended trying AbbVie's HIV combo therapy Kaletra to treat the new coronavirus ravaging the country—and spreading fast.