Yesterday was an important date for MAP Pharmaceuticals and Levadex, its new inhaled product for migraine. March 26, 2012 was the Prescription Drug User Fee Act (PDUFA) “action date” for the Levadex application. The action date is the date by which the FDA commits to provide a manufacturer a response to a new drug application (NDA). The FDA attempts to provide manufacturers (also known as “sponsors”) with a response to their NDA on or before the action date in most cases. The action date is usually ten months from the date the NDA was filed, expect in the case where “priority review” is granted and then the time clock is six months.
Drug approval is a very complex process, wherein the FDA assesses (among other things) the safety, efficacy and manufacturing processes of a new drug before it is approved for use. There are a number of options the FDA has on the action date, but they essentially are:
- Approval, wherein the drug is approved for use under specific labeling (which guides doctors on how and when to prescribe, including important safety information).
- Approvable, wherein the FDA tells the sponsor what steps are needed to grant approval; these steps usually involve further clinical studies to assess issues (like safety or efficacy) that may have arisen
- Not-approvable, which as the name suggests, is where the FDA tells the sponsor that the drug will not be approved (they do tell the sponsor why!)
- Complete Response, where the FDA tells the sponsor about other issues that it is still assessing and/or information that it requires to approve the product.
Yesterday, Levadex received a Complete Response from the FDA. Here is a quote from the MAP Pharmaceuticals press release:
“In the Complete Response letter, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.
The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval. The Company is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name. The Company continues to pursue approval of LEVADEX for the acute treatment of migraine in adults.
MAP Pharmaceuticals plans to request a meeting with the FDA to discuss the issues raised in the Complete Response letter.”
You may see potentially misleading headlines like “FDA Refuses to approve Levadex” and “Levadex rejected by FDA”. While it is true that the FDA did not approve Levadex yesterday, it most definitely did not “reject” it! Looking at what the company stated in its press release, it appears that there were some unanswered questions about the manufacturing process and the FDA requested some information late in the process about the usability of the Levadex inhaler. Neither of these appears to be a “show stopper”. Importantly, they note that no issues with safety or efficacy have arisen, which certainly sounds encouraging!
We will follow the news on this story and see how it develops and keep you apprised here on Migraine.com