Gilead Sciences, Inc. has announced the submission of a New Drug Application(NDA) to the US Food and Drug Association(FDA) for “Lenacapavir” to fight against HIV-1.
The NDA is supported by extensive pre-clinical research and early clinical research and CMC. In February FDA have some concerns related to Chemistry Manufacturing and Controls (CMC).
Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established
Over the years for 35 years Gilead-Sciences, Inc. has developed 11 medicines for HIV-1. The biopharmaceutical company through its advancement in medical research has saved millions of people worldwide who are affected by HIV. The company created the pill regimen for HIV in its early stages.
was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.
Jared Baeten, MD, PhD, Vice President HIV Clinical Development, Gilead-Sciences said “We are committed to addressing unmet needs and recognize the urgency for filling the critical treatment gap for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy.”