FDA staffers gave a thumbs up to Merck's blockbuster cholesterol drug Vytorin in patients with kidney disease, providing a boost to one of the drug giant's ($MRK) key pipeline programs ahead of an expert panel meeting on the drug this week.
Merck wants an additional approval of the drug, which already generates billions, for patients with kidney disease, and the Whitehouse Station, NJ-based company has data from a 9,000-patient clinical trial to support that effort. Reviewing data from Merck, FDA staffers said that the drug lowered cardio risks such as heart attack rates among patients with chronic kidney disease, Reuters reported. And the staffers' remarks bode well for the drugmaker's big day in front of panel of experts on Nov. 2.
Another key comment from the FDA review might also help propel Vytorin as Merck aims for serving millions of kidney disease patients with the drug. The review said that the drug is unlikely to advance cancer, Bloomberg reported, potentially reducing fears about the drug that were sparked after a study revealed in 2008 showed that patients on the drug had increased cancer rates. Merck has been working on various fronts for years to show that the spike in cancer in that trial was by chance rather than the activity of the treatment, which is a combination of the long-used cholesterol drug Zocor and the newer heart treatment Zetia.
An FDA green light of Vytorin in the kidney disease population would be would add a big victory to Merck's late-stage product successes this year, which include major approvals for the hepatitis C drug boceprevir and the combo drug Juvisync for controlling cholesterol in diabetics.