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Gilead Requests Approval of Twice a Year HIV Medication

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Gilead Sciences submitted a new drug application to the U.S. Food and Drug Administration on Monday. Gilead is seeking approval of the drug lenacapavir, a long-acting HIV inhibitor, which is under clinical study.The drug, which is an injection, is to be specifically used by people with multi-drug resistant HIV.

Lenacapavir inhibits HIV, specifically HIV-1, by interfering with the virus’ replication process.As part of the application, the FDA received data from the company on the safety and effectiveness of lenacapavir when taken every six months along with a regimen of antiretroviral medications.

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