ViiV Healthcare Gets FDA Green Light for Rukobia (fostemsavir) first-in-class Treatment for HTE HIV Patients

July 29, 20200

ViiV Healthcare, a company where GSK, Pfizer and Shionogi hold a major portion of the shares, announced approval by the U.S. FDA of Rukobia (fostemsavir), a first-in-class attachment inhibitor, for the treatment of HIV-1 infection. The drug is approved for use in combination with other antiretroviral (ARV) therapies in patients with multi-drug resistant infection, who have been heavily-treated with negligible outcomes due to either resistance or intolerance.

Rukobia 600 mg extended-release tablets will provide a treatment option for the Highly-Treatment Experienced (HTE) adults, who comprise of about 6% of the adults undergoing treatments and are at a great risk of AIDS progression. The drug is a novel first-in-class treatment, a prodrug which when enters the body converts to tensavir, a gp120 attachment inhibitor that attaches to the outer surface of the virus, and prevents it from infecting the immune cells. The drug is currently being reviewed by the EMA and ViiV healthcare will continue submissions to other regulatory authorities in other countries throughout 2020 and 2021.

This New Drug Application (NDA) underwent various expedited pathways including fast track and priority review, along with which it received breakthrough therapy designation with data from phase III BRIGHTE study supporting the approval. During the trial, Rukobia was orally administered, twice a day to 371 HTE adult patients, who continued to have high concentration of HIV-RNA in their blood. Under the main arm of the clinical trial, 272 patients received either blinded fostemsavir or placebo while 99 patients without any remaining fully active approved ARVs received open-label fostemsavir plus optimised background therapy. At the end of 96 weeks of undergoing treatment in this trial, 60% of the individuals (n=163) possessed undetectable HIV viral load  along with which they had significant improvement in the count of CD4+ T-cells. However, substantial reduction in the viral load was observed as early as on the eighth day of treatment and more than 50% of the participants had undetectable levels of HIV RNA after 24 weeks of treatment.

A cocktail of drugs is used to routinely treat patients with HIV, but the threat of virus mutating to a resistant form has been increasing in a past few years. HIV drug resistance report 2019, published by the WHO exposed an alarming surge in resistance to crucial HIV drugs namely, efavirenz and nevirapine. Hence, such advancements in research and treatment options are highly critical to deal with the complex and significant unmet needs for treatment of highly treatment-experienced HIV patients who have increased susceptibility to life-threatening complications.

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