February 16, 2016
By Alex Keown, BioSpace.com Breaking News Staff
KENNILWORTH, N.J. – The U.S. Food and Drug Administration rejected Merck ’s cardiovascular claims for its cholesterol-reducing drugs Zetia and Vytorin, the company announced this morning.
The FDA sent Merck a complete response letter regarding the company’s new drug application for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. A complete response letter is a note the regulatory agency sends informing companies that its drug applications cannot be approved in its present form. Merck sought approval for the drugs’ cardiovascular use following results of its Improve-It trial. This morning, Merck said it was reviewing the letter and will determine the next steps.
The FDA’s rejection was not totally unexpected, given a regulatory panel’s refusal in December to back Merck’s claims that Vytorin reduced risks of heart attacks in strokes in patients with coronary disease.
Zetia and Vytorin have both been approved for the reduction of LDL cholesterol in patients with hyperlipidemia. However, in a statement Merck said the effect of Zetia on cardiovascular morbidity and mortality has not been determined. Regarding Vytorin, which is a combination of Zetia and simvastatin, the FDA said there is no established evidence the drug has any incremental benefit on cardiovascular morbidity and mortality over and above what has already been established for simvastatin.
Sales of the two anti-cholesterol drugs were down in 2015, 5 percent for Zetia and 17 percent for Vytorin, RTTNews reported.
Following news of the FDA rejection, Merck had not taken a negative hit. The stock is currently trading at $49.62 per share, up slightly from Tuesday’s opening price of $49.40 per share.
However, the rejection for the expanded use of Vytorin comes only days after the FDA gave preliminary approval for IMPAX Laboratories generic version of Merck’s Vytorin. Preliminary approval means that the New Drug Application filed by Impax “meets all the quality, safety and efficacy standards for clearance but is subject to an automatic stay of final approval for up to 30 months pending the resolution of a patent infringement suit,” Seeking Alpha reported. Sales of Vytorin for the four dose strengths Impax received preliminary approval to develop generics for totaled $714 million in 2015, Seeking Alpha said.
The FDA’s refusal to support the expanded use of Zetia and Vytorin comes as the company continues to implement cost cutting plans that have caused the company to eliminate thousands of jobs over the past few years. In 2013, Merck targeted $2.5 billion in cuts in annual operating expenses by the end of 2015. At the time the cuts were announced, Merck Chairman Kenneth Frazier said the initiative to sharpen the company’s commercial and research and development programs “will make Merck a more competitive company, better positioned to drive innovation and to more effectively commercialize medicines and vaccines for the people who need them.” Merck officials expect the majority of savings from the implementation of the initiative, will come from marketing and administrative expenses and research and development.
