S-P’s Zetia gains US approval
pharmafile | October 22, 2003 | News story | |Â Â Â
Schering-Plough's Zetia, the first in a new class of cholesterol-lowering drugs that slow intestinal absorption of cholesterol has gained FDA approval.
Richard Kogan, former Chairman and outgoing Chief Executive and President of Schering-Plough, said: "Zetia is expected to be a major growth driver for Schering-Plough and an important new entry in the global cholesterol management market, now valued at $19 billion".
Analysts have predicted that the drug will reach peak US sales of $690 million by 2006 provided its safety profile remains sound.
Zetia is a key part of Schering-Plough's strategy to ease past the imminent loss of patent on its blockbuster allergy treatment Claritin.
Merck will be co-marketers of the product as part of a wider joint venture established to develop and market new cholesterol treatments.
Merck's Zocor was the world's biggest selling drug in 2001, and its combination with Zetia could sustain the older drug's sales as it nears patent expiry.
Zetia has been approved as a once-daily treatment either by itself or in combination with statins to reduce both LDL 'bad cholesterol' and total cholesterol.
Merck and Schering-Plough conducted clinical trials of Zetia either alone or with a statin in more than 4,700 patients. The trials showed Zetia to be generally well tolerated with an overall adverse event incidence comparable with that of the placebo.
The drug was tested in combination with the four best-selling cholesterol-lowering treatments: Merck's Zocor, Andrx's Altocor (lovostatin) Pfizer's Lipitor and Bristol-Myers Squibb's Pravachol.
Last year, in its guidelines on cholesterol, the US National Institutes of Health substantially expanded the number of Americans eligible for drug treatment and called for lower cholesterol goals for many patients.
The FDA also approved Zetia for use in two rare genetic disorders, in combination with either Lipitor or Zocor.
