In the news ... 2007

FDA Issues "Approvable" Letter for Marivirco

June 20, 2007

The FDA this afternoon issued an “approvable” letter to Pfizer concerning its new entry inhibitor, maraviroc. The drug has been declared “approvable” but it is not yet “approved.” This means that the FDA has agreed that the drug has been shown to be safe and effective, but that there are still other issues that need to be worked out with the company before they are permitted to sell the drug. The FDA was required by law to “respond” by June 20, 2007 to Pfizer’s application. This “approvable” letter is their response.

The main issue still under debate is the label indication. This includes the question of the type of patient the drug is being approved for, as well as the question of whether or not the Trophile diagnostic assay will be recommended or required before prescribing the drug. There may also be other issues as well.

It is not unusual for the FDA to issue an “approvable” letter instead of a formal approval, but it has never before happened with an HIV drug. In general, the FDA has gone right to “approved” for drugs that treat people with life-threatening illnesses. In this case, the FDA may have hoped to have finished the discussion about the label by June 20 but they weren’t able to do so. So the real “approval” still awaits us.

This also affects the announcement of the price. The final price won’t be set until the label indication is firmed up, as this will affect likely sales of the drug. It's not known if the approval will come in a few days or a few weeks. It will be approved, just not today.