Tuesday, January 17, 2012

Video-FDA Grants Fast-Track Status to Achillion’s Hepatitis C Drug

Jan 17, 2012
- 4:14 -
Achillion CFO Mary Kay Fenton on the benefits of the company’s new hepatitis C drug.

Press Release - Jan 4

Achillion hepatitis drug gets faster FDA review

AP)  NEW HAVEN, Conn. — A chronic hepatitis c treatment being developed by from Achillion Pharmaceuticals received fast track designation, allowing for a quicker review by regulators.

Achillion said Wednesday the treatment, labeled ACH-1625, is in mid-stage clinical testing. The designation allows drug developers to submit their applications to the Food and Drug Administration piece by piece instead of having to file all the paperwork at once.

It also allows for more frequent interaction with regulators and a possible priority review.

Achillion Pharmaceuticals Inc., based in New Haven, Conn., said the drug received the designation due in part to its once-daily dosing and its potential to offer improved safety and tolerability compared to the current standard of care.

Hepatitis C treatments represent a big opportunity for drugmakers. The virus can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. Analysts expect the market for those treatments to expand in the coming years.

Other companies developing potential drugs include Pharmasset Inc. which is being acquired by Gilead Sciences Inc. Earlier this year, the FDA approved two pills that offered the first new breakthrough treatments for the liver disease in 20 years. The Vertex Pharmaceuticals Inc. hepatitis C pill Incivek rang up about $420 million in this year's third quarter. Another pill, Merck & Co.'s Victrelis had $31 million in sales.

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