The Highs and Lows of 2017 – Cardiovascular, Metabolic, Renal, and Hematologic Diseases

DRG cardiovascular, metabolic, renal, and hematologic (CMRH) disease experts have compiled their top ten market events in 2017. Events run the gamut from the launch of novel products and expanded labels in key markets to unexpected pipeline failures. Because cardiovascular (CV) disease remains the leading cause of death in the United States, and the public health burden of CMRH diseases continues to grow, this is arguably the most important pharmaceutical space to keep an eye on! Below is a summary of our top 2017 year highs and lows.

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  1. Amgen reported positive results from its CV outcomes trial FOURIER for its PCSK9 inhibitor Repatha.  These CV outcomes data are the first to be released for a PCSK9 inhibitor; the trial demonstrated Repatha reduced major adverse CV events by 15%, further confirming the “lower for longer is better” approach to LDL cholesterol levels.
  2. Jardiance’s label was updated to include risk reduction in CV death in the U.S. and Europe. This is the first antidiabetic medication in Europe to have this type of label.
  3. Roche’s Hemlibra, the first new agent in nearly 20 years for patients with hemophilia A with inhibitors, received FDA approval in November 2017. Significantly, Hemlibra is the first subcutaneously administered, once-weekly hemophilia agent to be approved.
  4. Lower limb amputation warning was added to Invokana’s label. While Johnson & Johnson’s CV outcomes trial CANVAS yielded positive results on par with EMPA-REG, the increased amputation risk has created more questions than it answered.
  5. Results from the COMPASS trial in stable coronary artery disease (CAD) and peripheral arterial disease (PAD) patients demonstrated a CV outcomes benefit for the combination of low dose Xarelto (Bayer/J&J) and aspirin versus low-dose aspirin alone. These results are expected to further expand the oral anticoagulant’s label to encompass CAD and PAD, while also pointing to a new treatment direction for these indications, where antiplatelet agents have long dominated.
  6. Within the osteoporosis market, Radius Health launched a potential blockbuster, Tymlos. In contrast, Tymlos’s competitor, Amgen/UCB’s Evenity, had a disappointing year. An adverse CV safety signal in Evenity's pivotal Phase III trial has delayed its regulatory approval, and could lead to its discontinuation.
  7. Although lackluster, the results from canakinumab’s CANTOS trial validated the inflammatory hypothesis – leading the way for more anti-inflammatory agents to be developed targeting CV disease. Canakinumab is the first anti-inflammatory drug to show improved outcomes in post-acute coronary syndrome patients.
  8. AbbVie terminated its Phase III SONAR trial for atrasentan, an endothelin-1 receptor antagonist under development for diabetic kidney disease.
  9. New potassium binder sodium zirconium cyclosilicate received its second complete response letter. AstraZeneca continues to face challenges with its manufacturing facilities. Zirconium cyclosilicate’s delay, along with the termination of Ardelyx’s emerging potassium binder RDX-7675 has been a major win for Relypsa/Fresenius’s Veltassa.
  10. Newly approved Fiasp, an ultra rapid-acting insulin, helped address significant unmet needs in type 1 diabetes, particularly among young children. Owing to its faster onset of action coupled with a shorter duration of action, the drug can address the extreme swings in blood glucose troughs and peaks.