Memorandum

FDA approves label update for Saxenda to include three-year data from the SCALE trial – April 27, 2017

Novo Nordisk announced today that the FDA has approved the inclusion of three-year SCALE data on the label for obesity drug Saxenda (liraglutide 3.0 mg). Providers and patients will now more readily be able to see how Saxenda in combination with lifestyle modification led to 6% body weight loss vs. 2% with placebo at 160 weeks, and how ~50% of the individuals on Saxenda who lost ≥5% body weight at week 56 maintained this weight loss over three years. This long-term, sustained efficacy is impressive and the inclusion of this data on the label is valuable news for busy healthcare providers who rely on product labels to inform their practice. In addition to efficacy, the label update supports the long-term safety of Saxenda, which is critical in the realm of obesity – many patients/providers are wary of the the side-effects and adverse health consequences of weight loss pharmacotherapy, which is a major hurdle to prescribing these drugs and to adequately treating obesity. We so hope that this revised label encourages more patients/providers to consider Saxenda. We expect it’ll take concerted effort to spread awareness of the label update, but to this end, we were pleased to hear from Novo Nordisk reps at Diabetes UK that a sizeable part of the company’s R&D budget is dedicated to obesity, which not only covers clinical studies, but also supports campaigns to educate providers/payers on obesity as a biological, treatable disease. High cost of the drug and poor reimbursement prospects present other critical hurdles, but the Saxenda savings card may be a partial solution – eligible patients with commercial insurance could have co-pays as low as $30 and could save up to $200 per monthly or more per prescription. Overall, it’s clear that Novo Nordisk is committed to growing both Saxenda and the underlying class – Saxenda is a bright spot in the market with $233 million in revenue in 2016. We look forward to more commentary on the label update and the product’s financial performance during Novo Nordisk’s 1Q17 earnings call on May 3.

-- by Payal Marathe, Helen Gao, and Kelly Close