Quick Commercial Standouts Lacking Among 2016 US Launches

The number of novel drugs approved by FDA in 2016 was down versus prior years, and many of the drugs that did launch are off to a slow start. The expectation is increasingly for drugs to build sales over time.

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The novel drugs that launched in the US in 2016 were fewer than in recent prior years and those that did reach the market got off to a relatively lackluster start. The two outliers are in hepatitis C, which despite the quick successes is a challenging therapy area commercially over the long term because sales have already started to decline as patients are treated and cured.

There were 22 new molecular entities and novel therapeutic biologics approved by FDA’s Center for Drug Evaluation and Research and...

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