Memorandum

Novo Nordisk files liraglutide 3mg for obesity in the US and EU – December 21, 2013

Executive Highlights

  • Novo Nordisk has submitted liraglutide 3mg to the FDA and EMA with a standard obese / overweight with complications indication, placing potential approval in late 2014.
  • The company has stated that it plans to target patients who are more obese with either a history with or a desire to take anti-obesity medications; it will focus on providers that have experience with Victoza (liraglutide for diabetes) and/or anti-obesity medications.
  • If approved, liraglutide’s proven track record in diabetes will be an advantage, though marketing obesity therapy is not for the faint of heart; reimbursement, lingering pancreatitis fears, and the need for injections will undoubtedly slow patient uptake at least somewhat

Novo Nordisk just announced that it has submitted a new drug application (NDA) with the US FDA and a marketing authorization application (MAA) with the EMA for liraglutide 3mg, intended for patients who are obese (BMI of at least 30 kg/m2) or overweight with comorbidities (BMI of at least 27 kg/m2). This matches previous guidance from the company's 3Q13 update for a submission by the end of 2013 – see our Novo Nordisk 3Q13 Report for full details. During the update, management stated that it is hopeful for a 2015 launch and that is optimistic about approval given that no new side effects emerged in the 3mg dose's phase 3 SCALE program (see our Novo Nordisk 2Q13 Report for a more detailed look at the results of the SCALE studies). The press release noted that data from the drug's type 2 diabetes clinical program were also included in the submissions, which should benefit Novo Nordisk significantly as it provides a large volume of extra safety evaluation data.

Liraglutide for obesity was a major focus of Novo Nordisk's Capital Markets Day presentation earlier this month - see the slide set here and our write-up here. The company plans to initially target the relatively narrow slice of the at-risk population (~5% of the indicated population in the US) with a BMI over 35 kg/m2 who understand the link between obesity and health risks and have previously tried anti-obesity medications or are ready to do so.  In terms of its marketing efforts, Novo Nordisk intends to target providers that are familiar with GLP-1 agonists and/or other anti-obesity medications. This is a relatively small group of providers, as 20% of providers write nearly 80% of anti-obesity medication scripts in the US, according to IMS. Outside the US, the company will focus on private, self-pay markets. 

If approved, we will be interested to see how liraglutide 3mg will be priced (presumably the same way 1.8 mg is priced for diabetes), how it is dosed (we believe there will be fewer dosing “increments”) and how it differentiates itself from other anti-obesity medications - Vivus' Qsymia (phentermine/topiramate) and Arena/Eisai's Belviq (lorcaserin) are both on the market in the US, while Orexigen/Takeda's Contrave (bupropion/naltrexone) was resubmitted in the US earlier this year (Orexigen has previously stated that it expects a decision by June 2014). The competitive landscape is less crowded in the EU, as neither Qsymia nor Belviq have gained approval there, while Contrave was submitted in the EU this past October – it doesn’t matter nearly as much, however, since the EU has very little reimbursement and pricing (and therefore profitability) are much lower in the EU broadly speaking. In both the US, we believe liraglutide's established use in diabetes could help win over prescribers and that it will draw big interest from some patients. However, reimbursement is a major battle even in the US, and lingering fears (we believe quite unfounded) about pancreatitis and pancreatic cancer, and the need for injections (Qsymia, Belviq, and Contrave are tablets) also present big challenges. While comparisons between clinical trials are inherently difficult, Novo Nordisk has previously stated that it believes liraglutide's efficacy could slightly beat Contrave's (Qsymia is generally seen as the most efficacious, and Belviq the least, although it is associated with a relatively high response rate). We have questions on how liraglutide will be dosed; we hope to learn more about this soon and will be updating this report. We are also very interested, longer term, in seeing more research data, particularly on the extent to which liraglutide used in obesity prevents conversion to diabetes for people with pre-diabetes.

-- by Manu Venkat and Kelly Close