Glaxo Gains FDA Clearance for First HIV Prevention Injection

(Bloomberg) -- GlaxoSmithKline Plc received U.S. clearance for the first long-acting injection for the prevention of HIV, a significant development for the company as it prepares to split in two next year.

The U.S. Food and Drug Administration approved the drug -- apretude -- for use in adults and adolescents at risk of sexually acquiring HIV, Glaxo said in a statement late Monday. The injection is given as one shot every two months.

The approval is a major step forward offering people with HIV a more flexible option than daily oral pills -- the current standard of care for prevention dominated by two drugs from Gilead Sciences Inc.

The decision comes at a key moment for Glaxo as it readies to spin-off its consumer arm in mid-2022, leaving its pharmaceutical and vaccines business as a standalone company. Glaxo’s HIV arm ViiV Healthcare is a valuable part of the drugmaker’s remaining business , but investors have raised concerns over the patent expiration of one of its key HIV drugs, dolutegravir, in 2029.

Glaxo’s new HIV injection, also known as cabotegravir, should go some way to replacing those revenues in the coming years.

“People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the U.S., may want options beyond daily oral pills,” Deborah Waterhouse, ViiV chief executive officer, said in a statement. 

The development comes after Glaxo set out ambitions to develop a cure for HIV by 2030 at a investor event last month. The drug the company is eyeing as a potential cure is set to go into human trials next year.

ViiV is majority owned by Glaxo, with Pfizer Inc. and Shionogi & Co. as shareholders. The company struck a deal with Shionogi in September to co-develop a third-generation therapy for HIV patients that would extend dosing intervals in the treatment space to three months or longer.

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