Will OTC Lipitor Win FDA Approval?

Will OTC Lipitor Win FDA Approval?

March 4th, 2014 // 2:49 pm @

Lipitor, which is the biggest selling drug ever with more than $13 billion in sales at its peak in 2006, is very well known for its ability to lower LDL cholesterol levels. It has been studied in many randomized clinical trials with thousands of patients for years. These studies have show how important this drug is to treat various types of cardiovascular disease. That is why Lipitor has become a cornerstone of any cardiovascular disease treatment program.

The patent for Lipitor expired recently in the US and Europe, and the sales of the drug are just 15% of what they were at their peak in 2006. That is partially why Pfizer is trying to get approval for an OTC version of the blockbuster drug. An OTC Lipitor would be a big help to Pfizer, as it would help to recapture part of the market it has lost since cheaper generic versions started to come out in 2011.

As we look back at history, FDA has given its approval to several prescription drugs, converting them to OTCs. For example, Zantac, Claritin and Zyrtec are now available without a prescription. These prescription to OTC drug switches were found to be safe by FDA and had a well understood side effect profile.

Pfizer thinks that Lipitor could work as an OTC drug and is going to run another clinical study to support its theory. Pfizer recently started a 1200 patient trial to see if consumers that are taking OTC Lipitor will take their own blood tests at a pharmacy to see if the drug is improving their choleterol levels. This trial is going to measure if patients are able to make the appropriate health care decisions based upon their blood test results. The difference is that with other types of OTC drugs, they usually relieve external symptoms quickly and it is clear if they are working or not. Having high LDL cholesterol is bad for us in the long term, but it does not produce symptoms. FDA is not interested in people taking a drug that has no benefit for them, so it is important to measure if patients are going to go for their own blood tests.

Even if the Pfizer study is successful, FDA will not necessarily allow the drug to switch to OTC status. Merck tried to get approval for its own statin, Mevacor, to become OTC, but it was rejected. However, Lipitor has been studied a lot more than Mevacor. Also, Pfizer is only seeking OTC approval for its lowest dose – 10 mg. FDA may turn out to be comfortable with this. We’ll keep watch to see what FDA decides.

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