Achillion hepatitis drug gets faster FDA review
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.
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.
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.
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.
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
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