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Zydus Cadila seeks drug controller approval for oral medicine to treat anaemia in kidney patients

The company completed large-scale enrolment of its phase-3 clinical trials by early February in in patients with chronic kidney disease, both on dialysis and not on dialysis.

“The study demonstrated the noninferiority of Desidustat compared to Darbepoetin in the treatment of anaemia in patients with CKD who were not on dialysis,” the company stated.

Leading global pharmaceutical company Zydus Cadila has announced that it is seeking the Drug Controller General of India (DCGI) nod for a drug that can be used as an oral alternative to treat anaemia in patients with chronic kidney disease.

According to Zydus Cadila’s statement, the New Drug Application (NDA) submitted to DGCI for ‘Desidustat’ is “based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with chronic kidney disease (CKD), both on dialysis and not on dialysis”.

The company had completed large-scale enrolment of its phase-3 clinical trials by early February this year and as part of it, for CKD patients not on dialysis, the oral Desidustat was compared with Darbepoietin alfa injection, showing a comparable efficacy to the injection. “The study demonstrated the noninferiority of Desidustat compared to Darbepoetin in the treatment of anaemia in patients with CKD who were not on dialysis,” the company stated in its press release.

For CKD patients on dialysis, the phase-3 trial included comparing the efficacy of Desidustat with Epoetin alfa injection, wherein as per Zydus Cadila’s statement, “the study demonstrated the noninferiority of Desidustat compared to Epoetin in the treatment of anaemia in patients with CKD who were on dialysis.”

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With both phase-3 studies — CKD in patients on dialysis and those not on dialysis — the primary endpoint considered was the change in haemoglobin levels as per the details on Clinical Trials Registry in India and as per the pharmaceutical company, “Desidustat met its primary efficacy endpoint in both Phase 3 trials,” with the data expected to be presented “at upcoming scientific meetings and published in peer-reviewed scientific journals.”

Pankaj Patel, chairman of Cadila Healthcare, was quoted in the press release as stating, “..Desidustat has the potential to provide an oral, safer alternative to currently available injectable erythropoietin- stimulating agents (ESAs), by additionally reducing hepcidin, reducing inflammation, and better iron mobilisation.”

In April this year, Desidustat was also registered for a phase-1 clinical trial to evaluate the safety of the drug for the treatment of anaemia in patients receiving chemotherapy.

First published on: 24-11-2021 at 10:52 IST
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