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Key Points
- US FDA has approved Gilead’s twice-yearly HIV prevention jab, branded as Yeztugo.
- Lenacapavir injection proved nearly 100 per cent effective in large-scale clinical trials.
- Gilead is planning a rapid launch in the US as well as a wider rollout of the drug in collaboration with global partners.
The US Food and Drug Administration has approved Gilead Sciences’ lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents.
Investors and AIDS activists had been eagerly awaiting the regulatory decision for the drug with the potential to help end the 44-year-old HIV epidemic.
The drug will be sold under the brand name Yeztugo in the US at a list price of $43,300 (US$28,218) a year.
Lenacapavir, belonging to a group of drugs called capsid inhibitors, demonstrated almost 100 percent effectiveness in preventing HIV during significant trials last year. This success has sparked new optimism about stopping the transmission of a virus that affects 1.3 million individuals annually.
Yeztugo “will only be as effective as it is accessible and affordable,” Kevin Robert Frost, CEO of the Foundation for AIDS Research, said in a statement, calling on Gilead and the US government to make sure people who want lenacapavir can get it.
Gilead said it will provide co-pay assistance for eligible insured people and that the drug may be made available free of charge under its program for the uninsured.
Medications to prevent HIV, known as pre-exposure prophylaxis or PrEP, are widely available. But most are daily pills, including low-cost generic versions of Gilead’s older drug Truvada, that require strict adherence to be effective.
Gilead said Yeztugo is priced in line with other branded drugs.
“This is a milestone moment,” said Gilead chief executive Daniel O’Day of the approval.
“We believe that lenacapavir is the most significant tool we have so far to change the course of the epidemic and eventually consign it to history,” O’Day stated.
Gilead has plans for a rapid launch in the United States as well as a wider rollout of the drug in collaboration with global partners.
Gilead chief commercial officer Johanna Mercier said the company’s “end game” is to normalise PrEP usage, both in the United States and other countries, including low-income African nations where the virus is most prevalent.
