UNITED KINGDOM – GlaxoSmithKline Plc (GSK) has reported positive trial results for Daprodustat, a potential blockbuster anemia pill that the drugmaker hopes will bolster its pharma portfolio as it prepares to spin off its consumer healthcare business next year.
According to data presented by the drugmaker, oral treatment for patients with anemia due to chronic kidney disease either maintained or improved hemoglobin levels compared to current medication, without increasing the cardiovascular risk.
The findings place GSK in the running for one of the first anemia treatments in pill form for both dialysis and non-dialysis patients in the United States and Europe.
The company had been trailing two other similar treatments developed by AstraZeneca Plc and its partner FibroGen Inc., as well as Akebia Therapeutics Inc. and its partner Otsuka Pharmaceutical Co., but both have suffered setbacks in the last 18 months.
GSK and its competitors’ treatments have already been approved in Japan, where regulators do not require data on cardiovascular impact, as well as in some other markets.
None have yet received approval in the United States or Europe. Akebia has applied to the US Food and Drug Administration for approval, and a decision is expected by the end of March.
GSK intends to submit its findings to regulators worldwide in the coming months, having released the first high-level positive trial results in July.
More than 700 million people worldwide suffer from chronic kidney disease, with one in every seven developing anemia.
In order to manage the condition, patients must currently receive injections. GSK hopes that its oral drug, Daprodustat, will be among a new crop of key revenue generators for its revamped pharma and vaccines division after it separates from its consumer arm in mid-2022.
GSK’s data shows that the drug has no increased heart risk for dialysis or non-dialysis patients when compared to an erythropoietin stimulating agent, which is the current standard of care.
This has been one of the issues that has hampered other drugmakers, raising concerns that cardiovascular side effects may be a class-wide issue for the drug type.
Though already approved in Japan as Duvroq, the drug’s future in the United States, where the same-class drug Roxadustat received an FDA complete response letter, remained unknown.
This is largely due to the FDA’s resounding rejection of Fibrogen and Astrazeneca’s Roxadustat earlier this year, which was based on cardiac and other safety concerns that some suspect was a class effect.
Given the European Medicines Agency’s (EMA) acceptance of Roxadustat’s much more doubtful results, Europe’s approval of Daprodustat appears assured. GSK, on the other hand, may require US approval to make Daprodustat pay.