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GSK’s HIV venture fails to get USFDA approval for once-a-month injection

The HIV venture led by GlaxoSmithKline Plc failed to win US approval for a once-a-month injection that aims to free patients from daily doses of medication.

ViiV Healthcare received a complete response letter from the Food and Drug Administration, which cited “chemistry manufacturing and controls,” according to a statement from the HIV unit Saturday. There haven’t been any safety issues reported, ViiV said.

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.

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.

Source: Business Standard