Gilead resubmits new HIV drug Lenacapavir marketing application
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Gilead resubmits new HIV drug Lenacapavir marketing application, requiring only two doses per year
On June 27 , Gilead announced that it had resubmitted to the U.S. Food and Drug Administration (FDA) its development of a long-acting HIV-1 capsid inhibitor, Lenacapavir, for the treatment of severe multidrug-resistant (MDR) HIV-1 infection. (HTE) New Drug Application (NDA) for HIV-1 infection in patients .
If eventually approved, Lenacapavir would be the first and only HIV-1 regimen to be administered twice a year.
This time, Gilead resubmitted the NDA for Lenacapavir .
In February 2022 , the FDA issued a Complete Response Letter ( CRL ) questioning the Chemical Manufacturing and Control ( CMC ) issue of the borosilicate glass vial’s compatibility with Lenacapavir injectable solution .
The NDA resubmission contains comprehensive CMC data to support the compatibility of Lenacapavir with alternative vial types made of aluminosilicate glass.
In addition, the NDA is supported by extensive preclinical and early clinical study data and data from the Phase 2/3 CAPELLA study evaluating the antiviral activity of Lenacapavir administered subcutaneously every six months in combination with other antiretroviral drugs For persons with severe treatment experience with multidrug-resistant HIV-1 infection.
Once the NDA is accepted by the FDA , a new Prescription Drug User Fee Act (PDUFA) date will be set.
“Due to resistance to multiple antiretroviral therapies, some people living with HIV have very limited treatment options,” said Jared Baeten , MD, vice president of HIV clinical development at Gilead Sciences . “We are committed to addressing unmet needs and Recognize the urgency of filling critical treatment gaps for patients with multidrug-resistant HIV whose virus is no longer responsive to current treatments.”
Gilead resubmits new HIV drug Lenacapavir marketing application
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