Tags: Regulators | Vertex | Hepatitis | Trial

Regulators Put Partial Hold on Vertex Hepatitis C Trial

Thursday, 25 Jul 2013 06:29 PM

Vertex Pharmaceuticals Inc. said U.S. regulators placed a partial clinical hold on its trial of a drug for hepatitis C after patients receiving a higher dose of the medicine showed signs of potential liver toxicity.

The Food and Drug Administration hold is on a study using a dose of 200 milligrams of the drug VX-135, the Cambridge, Massachusetts-based company said Thursday in a statement. The trial, in the second of three phases generally required for approval, is continuing in the 100-milligram dose.

Three patients taking 400 milligrams of the drug in combination with ribavirin in a European trial had elevated liver enzymes, and their levels returned to normal after they stopped treatment, Zach Barber, a spokesman for Vertex, said in an e-mail. The company said it’s finished dosing a 12-week study in Europe that included a 200-milligram arm and no serious adverse events or liver or heart safety issues arose.

“Developing safe and effective medicines for patients is our goal,” Robert Kauffman, Vertex chief medical officer, said in the statement. “We are committed to continuing to work closely with the FDA to provide the data needed to support evaluation of a 200 mg dose of VX-135 in the U.S.”

Vertex declined 10 percent to $78.87 at 4:34 p.m. New York time in extended trading after the announcement. The shares had more than doubled this year to $87.62 as of the close today.

Vertex is competing with drugmakers including Gilead Sciences Inc., AbbVie Inc. and Bristol-Myers Squibb Co. to develop an oral hepatitis C treatment that doesn’t involve injections of interferon, which can cause flu-like symptoms. The hepatitis C virus, which attacks the liver and can lead to liver cancer, affects about 150 million people worldwide.

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Vertex Pharmaceuticals Inc. said U.S. regulators placed a partial clinical hold on its trial of a drug for hepatitis C after patients receiving a higher dose of the medicine showed signs of potential liver toxicity.
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2013-29-25
Thursday, 25 Jul 2013 06:29 PM
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