On the day it was confirmed that Mylan has made a submission to the US Food and Drug Administration to market generic Vytorin, the agency has said it is unlikely Merck & Co’s cholesterol increases the risk of cancer.

Since August 2008, the FDA has been looking at a possible association between the use of Vytorin, a combination of simvastatin (Zocor) and ezetimibe (Zetia) and an increased risk of cancer and cancer-related death compared to placebo. Now, following a review of the results from the controversial 1,873-patient SEAS trial and of interim data from two large-scale ongoing cardiovascular trials with Vytorin – SHARP and IMPROVE-IT – the agency believes “it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death”.

However the FDA adds that “at this time an association cannot be definitively ruled out”. In the SEAS trial, cancer was reported in 105 patients (11.1%) in the Vytorin group and in 70 patients (7.5%) in the placebo group. The number of deaths from cancer was also higher in the Vytorin group (39 to 23).
An interim analysis of the cancer data from SHARP and IMPROVE-IT, which includes 20,617 patients, did not show an increased risk of cancer with Vytorin. The number of cancer-related deaths (97 for Vytorin compared to 72 in the control groups) is not statistically significant.

The FDA added that when completed, the trials will provide additional data to further assess cancer risk with simvastatin and ezetimibe. The SHARP trial is expected to be completed in 2010 and IMPROVE-IT in 2012.

Merck suing Mylan
Pretty good news for Merck which has filed a patent infringement lawsuit against Mylan after the latter filed an Abbreviated New Drug Application with the FDA for its versions of Vytorin.

Mylan believes it is the first to file such an ANDA and expects to qualify for 180 days of sole marketing exclusivity. US sales of Vytorin were approximately $1.6 billion for the 12 months ended September 30.