Gilead Sciences says Phase III trials for chronic HBV drug meet primary endpoints

pharmafile | April 15, 2016 | News story | |  Gilead Sciences, US FDA, chronic hepatitis B, drug trial 

Biotech firm Gilead Sciences (NYSE: GILD) on Friday announced positive results from late-stage trials for its drug to treat chronic hepatitis B virus (HBV) infection.

The trials showed improved renal and bone laboratory safety parameters compared with its Viread (tenofovir disoproxil fumarate).

Norbert Bischofberger, chief scientific officer, Gilead Sciences, said: “Chronic hepatitis B infection is a life-threatening disease that can lead to liver failure, liver cancer and death. With millions of people living with the disease it remains a significant health concern worldwide. The TAF Phase 3 results presented this week demonstrate its potential to advance the treatment of HBV – offering a similar efficacy profile to Viread with improved bone and renal safety parameters.”

Based on trial results the company has submitted a new drug application with the US Food and Drug Administration (FDA) and the FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 11, 2016, Gilead said in a statement.

Noting that discontinuations due to adverse events were not common in both treatment arms, the company said the most commonly reported adverse events in the studies included headache, upper respiratory tract infection, nasopharyngitis and cough, and occurred at similar rates in patients receiving either TAF or Viread.

Gilead also has submitted regulatory applications for the drug in the European Union and Japan.

The drug, tenofovir alafenamide or TAF, as a single-agent for chronic HBV is in trials and its safety and efficacy have not been established.

Anjali Shukla

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