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 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.
GSK intends to submit its findings to regulators worldwide in the coming months, having released the first high-level positive trial results in July.
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.
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.