Gilead bags first approval for twice-yearly HIV therapy

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The European Commission has become the first regulator worldwide to approved a therapy from Gilead Sciences for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, after the FDA rejected it earlier this year.

Sunlenca – based on HIV capsid inhibitor lenacapavir – has been approved in the EU for use as an add-on to antiretroviral therapies in patients who are struggling to achieve viral suppression with current drugs. It is dosed as an injection given every six months after an initial oral dose-loading course.

Once launched, it will compete with Rukobia (fostemsavir) from ViiV Healthcare, Gilead's biggest rival in the HIV market, which was approved for MDR HIV in the EU last year and the US in 2020, but needs to be taken orally every day. Rukobia made £35 million ($41 million) in the first half of 2022, and £45 million in 2021 as a whole.

The FDA turned down Gilead's first marketing application for Sunlenca in February over concerns about with the drug's manufacturing, specifically issued related to the possibility of sub-visible particulate contamination from the borosilicate glass vials that were originally used to produce the drug.

Gilead swapped to an alternative vial made from aluminosilicate glass and refiled the drug in June, and is now hoping for approval from the FDA by its review data of 27 December.

"Additional regulatory filings and decisions by regulatory authorities are anticipated to continue throughout 2022," said the drugmaker in a statement.

Gilead also intends to extend the use of lenacapavir into additional and larger patient settings, including the general HIV-positive population as well as for pre-exposure prophylaxis (PrEP) among people who have sex with HIV-positive partners.

Analysts at RBC Capital markets have previously predicted that lenacapavir could become a $4 billion blockbuster if it gets a green light across all its planned indications.

Broader use could bring lenacapavir into competition with ViiV's long-acting injectable Cabenuva (cabotegravir/rilpivirine), partnered with Johnson & Johnson, which is delivered monthly as an alternative to daily ART and was recently approved for use without an oral lead-in period.