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Fostemsavir is a "first-in-class" HIV attachment inhibitor.
it is a precursor drug (pro-drug) of temsavir.
Tesavir is able to combine with the GP120 subkey of the HIV-1 envelope glycoprotein gp160 complex to block the interaction between the virus and the cell CD4 receptor, thus preventing the infection of host cells.
,77V Healthcare developed to treat multi-drug-resistant HIV-1 adults in combination with other antiviral drugs.
previously, the FDA has granted fostemsavir breakthrough therapy recognition and fast-track eligibility.
its application for a new drug was also eligible for priority review.
Picture Source: References, The Safety and Effectiveness of Rukobia was evaluated in clinical trials including 371 adult patients who received multiple treatments.
these patients still have high levels of the virus in their blood, despite taking antiretroviral drugs.
most participants received HIV treatment for more than 15 years (71%), received five or more HIV treatments (85%) and/or had a history of AIDS (86%) before entering the trial.
results showed that after 24 weeks of rukobia with other antiretroviral drugs, 53 percent of participants had HIV-free RNA levels in their blood that were considered undetectable. After 96 weeks
, 60 percent of the participants continued to have suppressed RNA levels with HIV. "This approval marks a new type of antiretroviral drug that could benefit patients who have exhausted their HIV treatment options," said Dr. Jeff Murray, deputy director of the antiviral drug division at the FDA Center for Drug Evaluation and Research, after receiving Rukobia treatment for virological inhibition (Photo: ViiV Healthcare).
"new types of antiretroviral drugs are critical to people with multiple drug-resistant HIV who have received multiple treatments and may help those who are at higher risk of HIV-related complications live longer and healthier lives."
" References: FDA Approves New HIV Treatment for Patients With Limited Treatment Options. Retrieved July 2, 2020, from
2 s ViiV Healthcare Announces US FDA For Rukobia (fossavir), a First-in-Class For HIV in Adults With Sed SerDS Options. Retrieved July 2, 2020, from
Original Title: FDA Today Approves New Mechanism for Anti-HIV Drugs for The Benefit of Multidrug-Resistant Patients.
