Vertex Told to Place Hold on New Hep-C Drug
According to the Wall Street Journal, the U.S. Food and Drug Administration has ordered for a temporary hold on phase II clinical trials for Vertex’s new Hepatitis C drug, VX-135.
About the Vertex Hepatitis C Drug Hold
- The hold affects the 200 miligram dose of VX-135.
- The FDA ordered the hold after finding that 200 miligram dosage led to elevated levels of liver enzymes in some trial patients.
- An increase in the level of liver enzymes is often a sign of possible side effects.
Vertex and the Hepatitis C Drug Market
Vertex began to focus on developing a new hepatitis C drug in response to declining sells of Incivek which was released by the company in 2011. The drug was linked to a dangerous and potentially fatal skin rash causing doctors to recommend that patients wait for a future drug.
Hepatitis C drugs have become more lucrative due to the disease's prevalence. Approximately 170 million people are hepatitis C positive, granting the drug industry what experts expect to be a multi-billion dollar market.
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