EU: EMA shares draft recommendations on developing drugs for chronic liver diseases

30-11-2018

EU: EMA shares draft recommendations on developing drugs for chronic liver diseases

(Source: RAPS 2018-11-30)

EMA has released a draft reflection paper setting out its recommendations for developers of drugs to treat chronic, non-infectious liver diseases. The paper is intended to help companies develop drugs to treat significant unmet medical needs such as nonalcoholic steatohepatitis (NASH).

Major drug developers including Gilead Sciences and Novartis are targeting NASH and the other liver diseases covered by the reflection paper, namely primary biliary cholangitis and primary sclerosing cholangitis. The therapeutic and financial impact of these medicines could be significant, but only if the companies successfully navigate the challenges posed by the specifics of the diseases.

EMA drafted the reflection paper to help companies overcome the challenges. With that in mind, the text provides general recommendations and sketches out development strategies for each of the liver diseases. EMA plans to firm up the strategies once companies have brought drugs targeting the disease to market.

The agency is accepting feedback on the draft until the end of August.

More Information On RAPS

EMA Draft Paper

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