You knew this was coming

You knew this was coming

According to a press release from Takeda “Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application (NDA) with the United States Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of FDA’s December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.

Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional CV studies with alogliptin. Alogliptin’s Prescription Drug User Fee Act (PDUFA) date – June 26, 2009 – remains unchanged. “

This is VERY bad news for all the companies who have a diabetes drug either at the FDA or on its way to the FDA. The people at Novo Nordisk (NYSE:NVO), who’s GLP-1 Liraglutide is also awaiting FDA approval, must be wondering if their data set will meet the ever changing FDA requirements. This also makes the April panel meeting on Liraglutide a CRITICAL event. Although the FDA has yet to make public the agenda for this panel meeting which outlines the questions they want answers to, it’s not an overstatement to say the future of GLP-1 therapy is a stake.

When the new guidelines for approving diabetes drugs were announced many assumed that drugs already at the FDA would not be subject to these stricter guidelines. Basically these drug candidates would be grandfathered in and looked at under the old rules. Simply put the FDA has changed the rules of the game while the game is being played.

The folks at Amylin (NASDAQ:AMLN) already facing a nasty shareholder battle cannot be happy with this news as they are getting set to submit the long-acting once-a-week version of Byetta to the FDA by the end of the second quarter.  Although the company has publicly stated they have had several discussions with the agency, today’s news throws a monkey wrench into the works. How can Amylin or any company for that matter trust anything the agency says when they keep changing the rules of the game?

It should not go unnoticed that the agency still has not come back to Amylin with what label changes are needed for the current version of Byetta. Nor have they approved Byetta for use a monotherapy. Officials inside the company must be frustrated as the agency has more than enough data to make both decisions but for reasons only the FDA seems to know nothing is being done.

Without a director leading the agency it appears no one wants to take ownership of any decision.  Already under intense pressure from members of Congress for previous blunders the agency has gone into full blown protect mode which is slowing the drug approval process to a crawl.

When these new guidelines were adopted Diabetic Investor speculated that the agency had opened a Pandora’s Box which would only make matters worse. The one glimmer of hope was that drugs already at the agency would not be subject to the new guidelines. Today’s announcement is a clear signal this sliver of hope has disappeared.

Diabetic Investor cannot overstate just how bad and far reaching this news is. Today’s news is like playing a baseball game and in the middle of the fifth inning telling batters they get four strikes instead of three and that an inning doesn’t end until the team in the field gets four outs instead of three. 

It’s also points a deeper problem for every drug company who’s had discussions with the FDA. How can they believe anything the agency says? Worse how can they make any public statements given that the agency’s word is basically worthless? There is no question major reform is needed at the FDA but if this is reform Diabetic Investor shudders to think of what the agency is capable of. 

This decision by the FDA is a perfect example of government at its worst. You cannot simply change the rules of the game while the game is in progress. Worst of all millions of patients will continue to suffer needlessly while the agency flounders. This is truly a sad day.