Another Diabetes Drug Shot Down
This morning Biodel (NASDAQ:BIOD) became the latest causality from the FDA’s war against approving new diabetes treatments. According to a press release issued by the company; “Biodel Inc. (Nasdaq: BIOD) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) requesting additional information regarding the company’s new drug application (NDA) for Linjeta(TM) (human insulin [rDNA origin]) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.
The CRL stated that the FDA’s review cycle is complete and that the application cannot be approved in its present form. Biodel plans to contact the FDA within the coming weeks to request a meeting to discuss the company’s next steps and requirements for approval of Linjeta(TM).
The CRL included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls.
With regard to efficacy, the FDA stated that, in the type 1 trial analysis, excluding data from India was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy. In the type 2 trial analysis, the FDA acknowledged that non-inferiority was established in the completer population but stated that non-inferiority was not established in the intent-to-treat population because the agency did not consider a post-hoc modification of the statistical model as establishing conclusive evidence of efficacy. With regard to safety, the FDA commented that unequivocal non-inferiority needs to be achieved in order to compare the risk of hypoglycemia. The FDA requested that the company conduct two new phase 3 clinical trials using the commercial formulation, one in patients with type 1 diabetes and the other in patients with type 2 diabetes, to establish efficacy and safety as related to hypoglycemia and toleration.
The FDA also requested additional data related to stability and manufacturing. In addition, the FDA identified resolution of manufacturing issues related to recent site inspections at Hyaluron, Inc. and Wockhardt, Ltd. as a requisite for approval.”
Not unexpected shares of Biodel are getting hammered today already down nearly 50%.
Although the Biodel situation is not exactly the same as what happened to Bydureon, another drug the FDA has delayed, the two situations illustrate a disturbing trend. At time when everyone, including other federal agencies, acknowledges that the diabetes epidemic is worsening the FDA appears intent on doing everything within their power to stop new treatments from reaching the market. As so often happens in Washington D.C. the pendulum has swung from approving almost any drug to becoming ultra-conservative and not approving any new drugs. This new ultra-conservative environment at the FDA has broad implications in the diabetes marketplace. The stark reality is no company, drug or device, is immune from the over-zealous ultra-conservative members of the FDA, who no longer make decisions following the science. As Diabetic Investor has stated previously, fear not science is the overriding factor when approving a new drug or device.
The simple fact is the FDA knows they cannot be blamed for approving a medication or device, that turns out to have unexpected adverse events, by simply asking for more data. The way the FDA sees things it really doesn’t matter to them that patients need more and better drugs and devices to fight diabetes as long as they don’t get called before Congress again for approving a drug or device that eventually goes bad. Or but more bluntly the FDA’s new internal motto is CYA at all costs, patients be damned.
Rather than reach out to leading diabetes experts and strike a balance between being diligent but not over-zealous and ultra-conservative, the agency continues to listen to so-called experts like Dr. Steven Nissen, who while a respected cardiologist is not an expert in diabetes. Like the FDA, Dr. Nissen could care less that their combined efforts have resulted in irreparable harm to the millions of patients with diabetes who are not properly controlling their diabetes. Never mind that according to a recent government report which stated that by 2050 1 in 3 Americans will have diabetes or that diabetes is not just a healthcare crisis but an economic disaster as well. Thanks largely to the Avandia controversy, started by Dr. Nissen, the FDA is now an agency griped by fear.
Unfortunately, Diabetic Investor does not see conditions changing anytime in the near future. Like it or not, the reality is it will take time for the pendulum to swing back into the middle where it should be. This is actually good news for any company that has an approved drug or device on the market as the FDA is doing something that would be considered illegal if even attempted by a company in the diabetes market. The fact is the FDA is preventing diabetes drugs and devices from reaching the marketplace; products that would compete and possibly replace what’s already on the market.
Given this reality it would be wise for everyone to add a new risk factor when analyzing a new diabetes product and ask “Can this drug/device make it through the FDA?” The bottom line here is even with solid clinical data no drug or device is safe. With an ultra-conservative FDA, no adverse event, no matter how small or how insignificant can be overlooked. Considering the recent decisions by the FDA it doesn’t even matter if there are no serious adverse events found during clinical trials , as the agency could easily ask for more data based on the possibility of event occurring. This is not science which follows the data but what happens when science is thrown out the window.
At his very first inaugural address President Franklin Roosevelt uttered the now famous “the only thing we have to fear is fear itself” line however many focus on this one line without examining the full section which included this often quoted line which states:
“This is preeminently the time to speak the truth, the whole truth, frankly and boldly. Nor need we shrink from honestly facing conditions in our country today. This great nation will endure as it has endured, will revive and will prosper. So, first of all, let me assert my firm belief that the only thing we have to fear is fear itself- nameless, unreasoning, unjustified terror which paralyzes needed efforts to convert retreat into advance.”
It is time for the FDA to acknowledge that diabetes is the enemy and patients need better weapons. That now is not the time to pullback and stifle innovation, but charge ahead and attack. Or as Martin Luther King Jr. once wrote; “Our problem is not to be rid of fear but rather to harness and master it.”