FDA to Review Merck's Cardiovascular Drug Vytorin
Merck’s Vytorin
Merck and Co.’s (MRK) Vytorin is a cholesterol medicine that blocks the absorption of cholesterol from food and reduces the cholesterol the patient’s body naturally produces. Vytorin is a combination of two cholesterol drugs: Zetia, whose international nonproprietary name (or INN) is ezetimibe, and Zocor, whose INN is simvastatin. Vytorin contains both these drugs in a single tablet.
The US Food and Drug Administration (or FDA) has arranged a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (or EMDAC) on December 14, 2015.
Focus of the EMDAC meeting
Merck has approached FDA to approve Vytorin for the indications of reducing the risk of cardiovascular events like nonfatal myocardial infarction, unstable angina, nonfatal stroke, or cardiovascular death, in patients with existing coronary heart disease.
The committee will review the results of the IMPROVE-IT study for the use of Vytorin in reducing the risk of cardiovascular events.
What Vytorin does
Vytorin lowers the low-density lipoprotein (or LDL) levels, also known as bad cholesterol, and also lowers the total cholesterol by blocking the absorption of cholesterol from food. It also reduces the natural production of cholesterol in the patient’s body and lowers triglycerides, the fatty substances in the blood, and improves high-density lipoprotein (or HDL), which is known as good cholesterol.
Zetia and Vytorin are medicines used to lower LDL cholesterol levels. The combined sales for these two medicines amounted to $4.2 billion in 2014, a 3% decline compared with 2013. This decline was due to lower sales volumes of Vytorin in the US and Zetia in Canada, where they lost exclusivity. The above chart shows actual revenues for Vytorin over the last four quarters and estimated revenues for the next two quarters.
Some of the drugs that are used to reduce cholesterol levels include Pfizer’s (PFE) Lipitor, Merck’s Mevacor, Kowa Pharmaceuticals Livalo, AbbVie’s (ABBV) Niaspan, and AstraZeneca’s (AZN) Crestor. Investors can consider ETFs like the S&P 500 SPDR ETF (SPY), which holds ~0.8% of its investments in Merck and Co., or the Health Care Select Sector SPDR ETF (XLV), which holds ~5.5% of its total investments in Merck and Co., in order to divest the risk.
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