FDA Wary of GSK Oral Anemia Drug Risks

The new daprodustat medication from GSK was not looked upon favourably by an independent FDA suggestion group, who voted 11 to 5 that the drugs’ potential benefits do not outweigh the potential dangers for patients with chronic renal disease-related anaemia who aren’t receiving dialysis.

However, the panel of experts decided 13 to 3 that daprodustat’s planned usage in the dialysis-dependent community would be beneficial.

The prevailing consensus is that the products dangers are simply too great to be made up for by the aid it provides.

However, specialists did point out the necessity for both treatment alternatives within the market and patient autonomy for non-dialysis patients.

An oral drug would also be beneficial in terms of decreasing challenges affecting individuals who are reliant on dialysis and reducing the strain on dialysis units.

One drew attention to the trials’ brief duration, noting that the safety hazards would worsen in the long term.

Both roxadustat and vadadustat, two oral HIF-PH inhibitors produced by AstraZeneca, FibroGen, and Akebia Therapeutics, had already been rejected by the FDA.

SVP of development for GSK, Chris Corsico, expressed that a “robust discussion was an important step in the review of daprodustat. We are pleased the committee recognised the potential for daprodustat to help certain patients who are living with anaemia of CKD given limited treatment options.”

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