Is the FDA becoming too restrictive in the approval of new drugs?
I had a chance to review the FDA briefing documents on Amgens Denosumab and there is something amiss. The high level data on Neoplasms does indicate an increased rate of cancer of Denosumab vs. a placebo but what is missing is the incidence of Neoplasms within the general population. One would expect that the target audience for this new treatment would be at high risk for developing cancer and thus shouldnt have the FDA looked at the overall general population of the people who developed Neoplasms? Regardless the review of Denosumab should serve as a warning to drug companies that are getting ready to submit NDAs.
I obviously dont have a science background but when I saw the chart (see below) of the results of Denosumab vs. placebo I was a little taken back by the numbers and asked but how does this compare with the general population within the trial age groups? Im sure that when the data was submitted the folks at Amgen, while obviously having a vested interest, thought that there was no correlation between cancer and Denosumab. If Amgens medical and clinical people had thought so they obviously would have done more studies to clarify.
What is disturbing though is that an FDA panel did see a correlation that possible isnt there. This may signal a more cautious FDA, one that is not willing to take risks with new drugs, especially when there are others on the market for treatment of the same condition. Its now up to the FDA to determine if there is going to be a black box warning or other restrictions that could limit the sales of Denosumab.
For those of you who might not know drug companies continually work with the FDA when developing new drugs to ensure that clinical trials are designed correctly. The FDA can also bring up any issues it feels need to be addressed by the drug company so that the all the paperwork is submitted with the new drug application and the drug can be approved. When an FDA panel therefore states that they are concerned that Denosumab may have some issues medical and clinical people from the drug company scratch their heads in disbelief.
There are also bigger issues here that involve everyone. Since Denosumab is an injection that is administered twice a year one would think that compliance would not be an issue and that it could lead to a lower number of people requiring long term care because of fractures. Yes there are other drugs out there like Boniva and Reclast but they require either a patient taking the drug once a month (the Boniva website even has reminder tools to take the drug) or an IV infusion. I would think that a simple injection once every 6 months would be a lot easier for todays time stressed patients.
The result of the FDA panel is being reported by financial analysts everywhere now. Some feel Amgen got what they wanted others felt it could hamper the sales of Denosumab. Again lost if all this back and forth are the patients who could have benefitted from this new osteoporosis treatment and the healthcare system which could have benefitted by another treatment to prevent fractures. This is more than the glass is half empty or half filled its a sign that the FDA is going to analyze the hell out of all data and that drug companies are not only going to need to do more scenario planning it is a sign that drugs are going to be more expensive to develop at a time when cost containment is the golden rule.