FDA toughens up on approval standards - FDA trends

Maureen Martino — Fri, 13 Jun 2008 15:03:01 -0400

First, Merck was dealt a harsh rejection of Coredaptive, a combination of niacin and laropiprant that had been high up on the drug giant's list of potential blockbusters. Then Genzyme and Isis felt the FDA's wrath when the agency voted thumbs down on mipomersen, another cholesterol drug. Mipomersen will be delayed for several years as the drug developers conduct additional trials.

The back-to-back rejections had some analysts wondering whether the FDA is toughening up on the approval of new cholesterol drugs. It appears that it's no longer sufficient for a drug entering an already-crowded market to be safe and effective; the FDA wants to see a clear benefit over existing medications. These days, it isn't enough for companies to show that their drugs lower bad cholesterol. Drugs must demonstrate better outcomes, thanks largely in part to the recent dust-up over Vytorin. A study conducted by Merck and Schering-Plough showed that when it comes to arterial thickness, there was no significant difference between treatment with generic simvastatin (Zocor) and Vytorin, which combines Zocor and Zetia (ezetimibe).

"FDA has long approved drugs based on their ability to lower so-called bad cholesterol, which is widely believed to reduce heart attack and death," noted the AP. "But the Vytorin results suggest the connection between higher cholesterol and negative outcomes may not be as concrete as initially thought."

FDA staffers say there's been no official change in the agency's policy, but drugmakers may be facing long delays if they can't prove their drugs are significantly more effective that those currently available.

Cholesterol drug market shifts

Mon, 12 May 2008 06:59:58 -0400

Big-name cholesterol meds are losing ground on two fronts. First, the Pfizer cholesterol drug Lipitor--its biggest seller--is falling victim to cost-cutting in the U.K. Primary Care Trusts are steering patients off the brand-name statin and onto simvastatin (generic Zocor). Lipitor scrips written by GPs dropped by 15 percent in 2007, or about $103 million. That's bad news for Pfizer--but also for other drugmakers, Pharmafocus notes, because it shows that the trusts are exercising their influence over prescribing habits.

Second, sales reps pushing Vytorin--the Merck/Schering-Plough combo pill that's attracted so much negative press lately--have been failing to get doctors' attention. Instead, Abbott's Simcor is turning heads. Twenty-three percent of primary care docs and cardiologists are listening to Simcor pitches, versus 20 percent for Vytorin. And despite the fact that Simcor was just launched, it's rapidly gaining ground on the popular Vytorin, nabbing one-third the number of scrips Vytorin did last month.

- see the Pharmafocus story
- check out the item at Pharmalot

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