Glaxo’s HIV Venture Fails to Get FDA Approval for Monthly Shot

(Bloomberg) --

GlaxoSmithKline Plc and partners failed to win U.S. approval for a once-a-month injection that aims to free patients with HIV from daily doses of medication.

The U.S. Food and Drug Administration turned down the product for reasons related to “chemistry manufacturing and controls,” Glaxo said in a statement. The ViiV venture first reported the news on Saturday, saying there had been no safety issues linked to the medicine.

It’s a setback for Glaxo, which has been counting on the monthly therapy to help take on rival Gilead Sciences Inc. in the market for HIV medicines. The British pharma giant and partner Pfizer Inc. are betting that a two-therapy approach will simplify treatment and cause fewer side effects than the traditional three-drug therapies.

ViiV said it will work closely with the FDA to determine the next steps. Glaxo fell 0.8% to 1,798.40 pence in London trading.

The injection combines Johnson & Johnson’s rilpivirine with cabotegravir, which is being developed by ViiV, a venture between Glaxo, Pfizer and Japan’s Shionogi & Co. Studies earlier this year found that the monthly shots worked as well as a standard daily oral combination of three medicines in subduing HIV.

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