- Novo Nordisk A/S on Friday landed a new, heart-focused indication for its top-selling diabetes medicine, an achievement many drugmakers in the crowded therapeutic area have strived for as they try to differentiate their products.
- The Food and Drug Administration OK'd Victoza as a treatment for lowering the risk of three major adverse cardiovascular (CV) events among adults with type 2 diabetes and established CV disease. It is now the only type 2 diabetes drug to hold such an indication, according to an Aug. 25 statement from Novo.
- Victoza is part of a growing class of blood sugar regulators known as glucagon-like peptide-1 (GLP-1) drugs. While Novo's product used to dominate the GLP-1 space, its market share has dwindled as newer and longer-acting medications, such as Eli Lilly & Co.'s Trulicity, have gained FDA approval.
Friday's approval could help bolster Victoza (liraglutide)'s place in the GLP-1 market, as well as the wider diabetes space. That's good news for Novo, particularly because the drug comprises about 25% of the company's total diabetes care revenues. Victoza sales shot up 21% to DKK 11.5 billion ($1.7 billion) in the first half of 2017 compared to the same period the year prior.
Those strong sales notwithstanding, Victoza has been losing ground in the GLP-1 arena over the last few years. The drug used to hold around 70% of new prescriptions on the GLP-1 market prior to the launch of Trulicity (dulaglutide). Now, it holds around 45% of that market share, according to an Aug. 21 note from Cowen & Co. analyst Steve Scala.
Novo, meanwhile, claims that Victoza maintained a 54% share of the GLP-1 market as of June 30, according to the Danish drugmaker's most recent quarterly filing with the Securities and Exchange Commission.
Victoza's new indication is based on data from the late-stage LEADER trial that enrolled more than 9,300 type 2 diabetes who were at high risk of major adverse CV events. Patients receiving Novo's drug had an average 13% reduction in their risk of a three-component endpoint that included heart attack, stroke and CV death compared to placebo.
"Physicians have come to rely on Victoza as an effective therapy for lowering A1C, and with this new indication, they now have the option to choose a diabetes medication that also reduces their patient's cardiovascular risk," Anne Phillips, Novo's SVP of clinical, medical and regulatory affairs, said in the Aug. 25 statement.
In addition to Victoza, which is approved as a once-daily medication, Novo is working on a longer-acting product. Earlier this month, the company reported positive results from the Phase 3 SUSTAIN 7 study showing two doses of its once-weekly candidate semaglutide significantly outperformed Trulicity in lowering glycosylated hemoglobin levels. The company submitted a New Drug Application for subcutaneous semaglutide in December and is currently conducting a late-stage study for an oral version slated to complete next summer.
Novo shares opened at $46.74 apiece Monday morning, a little more than 1% higher than their value at close of market on Friday.