FDA grants Priority Review of NDA for Astex's oral C-DEC
Category: #health  By Saipriya Iyer  Date: 2020-02-12
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FDA grants Priority Review of NDA for Astex's oral C-DEC

Astex Pharmaceuticals, Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd., announced that it has received Priority Review for its NDA for oral C-DEC (cedazuridine and decitabine) by the U.S. Food and Drug Administration (FDA). Oral C-DEC is a treatment modality under development for adults with previously untreated high-and intermediate-risk MDS, such as chronic myelomonocytic leukemia (CMML). The proposal for NDA is supported by the data received from the ASCERTAIN phase 3 trial, which assessed the 5-day decitabine exposure equivalence of IV decitabine and oral C-DEC.

Dr. Mohammad Azab, MD, Chief Medical Officer and President, Astex Pharmaceuticals, Inc., reportedly stated that the company is gratified to receive acceptance of its NDA for Priority Review from the FDA and elated by the contribution of all the investigators, patients, other healthcare providers, and partner research & manufacturing organizations to the clinical development program of oral C-DEC. The oral C-DEC may offer a novel treatment alternative for patients suffering from CMML and MDS and release the burden of taking 5-day IV infusions every month during therapy, he further added.

The FDA accepts Priority Review applications of drugs, which, after approval, can deliver significant improvements in the effectiveness and safety of the medication, diagnosis or prevention of severe conditions. The Priority Review designation indicates the goal of the FDA to act on an NDA application in six months as compared to the ten months under standard review.

For the record, oral C-DEC is an investigational compound, which has not yet received any approval in any country.

In another news, the parent company of Astex, Otsuka Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd. announced that commercialization of oral C-DEC in Canada and the U.S. will be conducted by Taiho Pharma Canada, Inc. and Taiho Oncology, Inc. respectively. The commercialization will be subject to regulatory approvals.

Source link:

https://astx.com/astex-pharmaceuticals-announces-u-s-food-and-drug-administration-fda-acceptance-for-review-of-an-nda-for-the-combination-oral-hypomethylating-agent-cedazuridine-and-decitabine-astx727-or-oral-c-de/



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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