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Glaxo Unveils Positive Data for Potential Blockbuster Anemia Drug

Glaxo Unveils Positive Data for Potential Blockbuster Anemia Drug

GlaxoSmithKline Plc released positive trial results for a potential blockbuster anemia pill the company is hoping will bolster its pharma portfolio as the drugmaker prepares to spin off its consumer healthcare business next year.

Results from five studies found the oral treatment for patients with anemia due to chronic kidney disease either maintained or improved hemoglobin levels compared with current medication, without increasing the cardiovascular risk, according to data presented Friday.

The data make Glaxo a contender for one of the first anemia treatments in pill form for both dialysis and non-dialysis patients in the U.S. and Europe. The company had been lagging behind two other similar treatments from AstraZeneca Plc and its partner FibroGen Inc., and Akebia Therapeutics Inc. and partner Otsuka Pharmaceutical Co., but both have suffered setbacks over the last 18 months.

More than 700 million people globally suffer from chronic kidney disease, with one in seven estimated to develop anemia. Patients must currently undergo injections to manage the condition. Glaxo is hoping its oral drug - daprodustat - will be among a new line-up of key money-makers for its revamped pharma and vaccines company after it separates from its consumer arm in mid-2022.

In June, the company told investors it was forecasting annual sales of between 500 million pounds ($673 million) and 1 billion pounds. Glaxo first released high-level positive results from the trials in July.

There’s an opportunity “with an oral drug for the patients to, in some aspects, take a little bit more control of their disease because they’re no longer reliant at least for the anemia to have to go in to see the healthcare provider for an injection,” Chris Corsico, Glaxo’s head of development, said in an interview.

The data published Friday crucially shows the drug has no increased heart risk for dialysis or non-dialysis patients compared to an erythropoietin stimulating agent -- an injection that is the current standard of care. This has been one of the issues hampering other drugmakers, giving rise to concerns cardiovascular side effects could be a class-wide issue for the drug type. 

The treatments from Glaxo and its rivals have already been approved in Japan, where regulators don’t require data on the cardiovascular impact, as well as some other markets. None has yet secured authorization in the U.S. or Europe. Akebia has applied for approval from the U.S. Food and Drug Administration and a decision is expected by the end of March. Glaxo is planning to submit its results to regulators globally in coming months.

©2021 Bloomberg L.P.