FDA issued a not-approvable letter, but details were not revealed.



Merck & Co. received a second blow to its cholesterol-management program sending its stock down $7.72%. FDA issued a not approvable letter for MK-0524A, while earlier this year data was published showing that another Merck cholesterol product, Vytorin, was no more effective than a cheaper generic drug.


Merck opened the day at $38.24. The company’s shares have been trading below $42 ever since news of Vytorin. This is the lowest value the company has seen year-to-date.


Merck did not report the agency’s reason behind the not-approvable letter. The company says that it will meet with the FDA and submit additional data to support approval.


“In our opinion,” says Seamus Fernandez, pharmaceutical analyst at Leerink Swann, “the issuance of a not-approvable letter suggests a serious deficiency in the NDA. We are particularly surprised since the EMEA/CHMP concluded that the risk/benefit favored approval of the drug and Merck is conducting a major outcomes study. At a minimum, we expected FDA to issue an approvable letter pending the completion and results of the 20,000 patient HPS2-THRIVE study; results are likely in 2012.”


Merck only revealed that the FDA rejected the proposed trade name, Cordaptive. The company expects to pursue the alternative trade name Tredaptive. Merck reports that it submitted an NDA for MK-0524A for the treatment of primary hypercholesterolemia, or mixed dyslipidemia.








This site uses Akismet to reduce spam. Learn how your comment data is processed.