ViiV Healthcare’s Fostemsavir , A New HIV Med For Drug Resistant HIV Patients Submitted To US FDA For Approval
The global HIV
specialists pharma company, ViiV Healthcare
, majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, has filed a New Drug Application in the US for fostemsavir
, an investigational, first-in-class attachment inhibitor for the treatment of HIV
, the drug is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV
-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.
s chief executive Deborah Waterhouse told Thailand Medical
may provide an important treatment option for the group of people living with HIV
who, for a variety of reasons, are not able to suppress their virus with other medicines and could be left with few or no treatments available to them."
She added, "In keeping with our mission of leaving no person with HIV
behind, we have overcome many barriers to bring this important new medicine to people living with HIV,
including investing in what is a very complex manufacturing process. We look forward to working with the US FDA to make fostemsavir available to the people in the US who need it.”
The drug submission is backed by results from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV
. At Week 96, 60% of patients receiving fostemsavir
plus optimised background treatment (OBT) in the randomised cohort achieved virologic suppression, an increase of 6% from Week 48 results.
patients in the randomised cohort showed continued immunologic improvement through Week 96 as demonstrated by an increase in CD4+ T-cell counts.
Kimberly Smith, head of R&D at ViiV, “We’ve made incredible strides in our understanding and treatment of HIV
over the past 30 years. However, the complexities of the virus mean that unsuccessful treatment and antiviral resistance are still major concerns for certain people living with HIV
.Through our perseverance in research and development, these individuals may soon have an entirely new way to target and treat HIV
, aiding them in their efforts to achieve viral suppression.”
The new drug, Fostemsavir
has been granted US FDA Fast Track and Breakthrough Therapy Designations in the US.