Gilead's twice-yearly HIV therapy Sunlenca gets approval in EU
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The European Commission (EC) approved Gilead Sciences' (NASDAQ:GILD) Sunlenca (lenacapavir) injection and tablets to treat HIV infection in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Gilead said it was first global regulatory approval of Sunlenca, the only twice-yearly HIV treatment option.
The Marketing Authorization Application (MAA) was backed by data from a phase 2/3 trial called CAPELLA, the company said in an Aug. 22 press release.
Gilead said that the in July, the FDA accepted to review its resubmitted application seeking approval of lenacapavir. The FDA is expected to make a decision by Dec. 27.
In February, the FDA had rejected to approve the drug.