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Macugen to be reviewed by FDA advisory panel in August

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NEW YORK — Data on Macugen will be reviewed by a U.S. government advisory panel in August, the drug’s developers announced. A new drug application for the compound was filed with the Food and Drug Administration and was granted fast-track review status, the drug’s marketers said in a joint press release.

The new drug application for Macugen (pegaptanib sodium injection, Eyetech/Pfizer) was filed with the FDA last week as a treatment for wet age-related macular degeneration, according to the press release. Co-developers Pfizer Ophthalmics and Eyetech Pharmaceuticals submitted the drug under the Pilot 1 program, which allows the FDA to complete reviews of individual reviewable units within 6 months of submission and provide early feedback on the pre-submissions, the release said.

The submission was based on two phase 2/3 pivotal clinical trials for use of Macugen in the treatment of wet AMD. The drug is also in a phase 2 trial for the treatment of diabetic macular edema and a phase 2 trial for the treatment of retinal vein occlusion.