Juvisync approved!

You are probably asking yourself “What is a Juvisync?”  According to the FDA and several press reports, the agency has approved Merck’s combination Januvia/simvastatin. http://www.fiercebiotech.com/press-releases/fda-approves-combination-therapy-juvisync

Combining an oral type 2 agent with other type 2 agents (metformin / sfu) has been a common practice for years.  As FDA commissioner Mary Parks notes, this is the first combination type 2 / cholesterol lowering agent.  As type 2 diabetes and high cholesterol go hand in hand, this is a great play to expand the Januvia franchise.

Although Januvia is the dominant DPP-IV, it now faces increasing competition from Onglyza (BMS/AZ) and Trajenta (BI/Lilly).  The combination with simvastatin is a natural to lower patient pill burden and address two metabolic disorders.

With a generic simvastatin, it will be interesting to watch the pricing of Juvisync.  The traditional pricing strategy would be to offer at the current Januvia list price and essentially provide the simvastatin for free.  The benefit would be to expedite Juvisync coverage in commercially covered lives and importantly in Medicare Part D.  Nevertheless, a proven cholesterol agent (albeit generic now) and a broadly utilized type 2 agent in combination may offer a unique value proposition that may allow for a modest premium.  It is my guess that the more well-worn path of price parity to the parent branded agent will be taken.

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