Novo postpones Liraglutide Physician Training

Novo postpones Liraglutide Physician Training

According to story posted on the Financial Times web site; “Novo Nordisk (NYSE:NVO) has postponed pre-launch training sessions with US clinicians for diabetes drug liraglutide (Victoza)”. This news is not that surprising given the results of the FDA panel meeting. While liraglutide’s status at the FDA remains uncertain, on April 23rd the European Medicines Agency (EMEA) adopted a positive opinion, recommending marketing authorization, for Victoza®.  

Looking towards the future the story quotes Novo Nordisk’s chief science officer Mads Krogsgaard Thomsen who stated; “The agency could allow us to present our long-term calcitonin safety data in one dedicated meeting, or it could require a more lengthy procedure involving resubmission of the data, which could result in a delay of half a year or more.”

It’s unclear at the moment what the FDA will do as neither the agency nor Novo Nordisk have issued any public statements. While it’s known that Novo and the agency are talking it will likely be sometime before we know just how long the drug will be delayed.

Diabetic Investor does not consider it a foregone conclusion that the FDA will eventually approve liraglutide as many have speculated. This really has nothing to do with the drug itself and actually has more to do with the current glacial speed at which the FDA is proceeding. Considering that the agency pushed back the PUDFA date for Onglyza, Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca PLC (NYSE:AZN) DPP-4, from April 30th to July 30th, even with a positive panel result it’s clear the agency is proceeding cautiously with any new diabetes drug. This move along with the results of the liraglutide panel meeting is not overly great news for Novo.

While it would appear this is good news for Amylin (NASDAQ:AMLN) who currently has the only approved GLP-1, Byetta, on the market and is getting set to submit the once-weekly version of Byetta, Byetta LAR, to the agency before the end of this quarter, this news is a double-edged sword. On the one hand when your potential competition is delayed this is obviously a good thing. On the other when your potential blockbuster is about to go before the FDA in this uncertain regulatory environment, that’s a completely different story.

Amylin is already hip deep in a proxy fight which is evolving into a letter writing battle, needs this uncertainty like a raging forest fire needs gasoline.  Simply put by their lack of clarity the FDA is creating another quandary where one is not needed. Think of what their mixed messages are doing to the physicians who will eventually have to make the decision as to whether or not to prescribe these drugs. From all available data GLP-1 therapy is the most compelling therapy option for type 2 diabetes to come along in years. Besides excellent glycemic control, GLP-1 therapy offers the additional benefit of weight loss and little evidence of any increase in adverse cardiovascular events. Based on these facts one might think the agency would be egger to move aggressively to get more of these drugs onto the market.

Thanks to Dr. Nissen, it appears the agency has decided to look for any possible reason not to approve these drugs. It’s bad enough as it is for drug companies to deal with the new cardiovascular guidelines which the agency issued in response to Dr. Nissen’s now famous meta-analysis. But it’s even worse when the agency goes a step further and begins to investigate relatively minor issues and making them major issues.

Unfortunately this is exactly what Diabetic Investor was afraid of when the Avandia controversy first came to light. This controversy lead to the new cardiovascular guidelines and has created a foundation of fear within the FDA. More concerned with avoiding a possible mistake than approving potentially life- saving medicines, the approval process for new diabetes drugs has been turned upside down. With each piece of news it’s becoming uncomfortably clear that the agency has abandoned their mission of using evidenced based medicine to make decisions. As Edmund Burke once noted; “No passion so effectively robs the mind of all its powers of acting and reasoning as fear.”

One last note in regards to liraglutide, it doesn’t help the situation any when Novo throws more mud into an already muddy situation. One day stating that the thyroid cancer issues is a class effect, the next stating the drug is absolutely safe.  Simply put Novo wants to protect their insulin franchise and will do whatever they can to delay LAR from getting to market. Like everyone else they know that when it comes to GLP-1 therapy the mere fact that LAR is delivered once-weekly will trump liraglutide which is delivered once daily. They are also well aware that with each day liraglutide is delayed the more likely it is they would put in the difficult position of launching the drug shortly before or at the same time as LAR.  

As we noted previously Novo is almost in the exact same situation as Takeda whose DPP-4 is also facing a delay at the FDA. Like Novo, Takeda must decide whether it’s worth the time and expense to pursue approval when the strong possibility exists that even if they are successful at getting the drug approved, by no means a certainty, it would be extremely difficult to market the drug against the competition. For Takeda the situation is more problematic as they would likely be the third DPP-4 to come the market behind market leader Januvia and soon to be approved Onglyza. Novo for their part faces a somewhat different yet equally problematic situation. While liraglutide could be the second GLP-1 approved, LAR is game changing technology. The question for both Novo and Takeda is do they throw in the towel as Novartis (NYSE:NVS) did with Galvus or do they risk bringing a drug to market that would be basically inferior  to what’s already on the market or soon to be on the market?