quarta-feira, junho 20, 2007

FDA avança com maraviroc

Dum activista americano:

You may have noticed that this was the shortest press release you’ve ever seen for what looked like the approval of a new drug. This may be the first time some have heard this word “approvable” used. It’s not a mistake or typo. It is different than “approved.” Maraviroc 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 today to Pfizer’s application. This 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, and maybe include 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, I think they had hoped to finish the discussion about the label by today but they weren’t able to do so. So the real “approval” still awaits us. When the FDA issues an “approvable” letter in other, not so serious diseases, it is sometimes followed by announcement of requirements for additional studies. That is very unlikely to be the case here. The unfinished business, from the FDA’s point of view, is about the label indication.

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. I don’t know if the approval will come in a few days or a few weeks, though I’m inclined to think it’s only a few days off. But there is no question that the drug will be approved. Just not today...

For immediate release

June 20, 2007


NEW YORK, June 20 – Pfizer announced today the U.S. Food and Drug Administration (FDA) issued an approvable letter for maraviroc, which is under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1.

We continue our discussions with the FDA to address outstanding questions and finalize the product labeling as soon as possible. Pfizer is committed to making maraviroc available to the thousands of patients with HIV whose virus has become resistant to one or more currently available treatment options.

To date, more than 2,000 patients worldwide have received or are currently receiving treatment with maraviroc through clinical trials. Pfizer has also established an expanded access program (EAP) in 30 countries. The EAP is a clinical study that provides maraviroc in countries to patients who have limited treatment options prior to approval.

Pfizer is currently in the process of submitting marketing applications around the world to make maraviroc available globally.

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