FDA approves ‘Rukobia’ for HIV patients with limited treatment options
Category: #health  | By Mateen Dalal  | Date: 2020-07-04 |
  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn

FDA approves ‘Rukobia’ for HIV patients with limited treatment options

The use of antiretroviral therapies (ART) to battle HIV (Human Immunodeficiency Virus) is one of the great achievements of modern medicine. The ART medications can transform HIV from a fatal infection into a more manageable, chronic disease. As per the United Nations, the increased use of ART has been the main reason for a 48% decrease in AIDS-related deaths.

Recently, the ART landscape in the U.S got a new impetus when the US FDA (Food and Drug Administration) approved a new antiretroviral drug named Rukobia (fostemsavir) for the treatment of patients with AIDS. The agency has approved this drug to treat patients who have tried several HIV medications and whose infection can’t be treated with other treatments because of intolerance, resistance, and safety conditions.

Speaking on which, Jeff Murray, M.D, Deputy Director of FDA’s Division of Antivirals said that this authorization marked a new class of antiretroviral therapy that might benefit patients who tried several treatment options.

Mr. Murray added that the new antiretroviral drug is pivotal for patients who resist multiple HIV treatment options- helping people to potentially live longer and healthier lives.

Sources cite that the efficacy and safety of Rukobia were assessed in a clinical trial of 371 treatment-experienced patients who continued to have greater levels of (HIV-RNA) in their blood despite being on antiretroviral drugs.

After 24 weeks of evaluations, data demonstrated that around 53% of participants have attained HIV RNA suppression, where HIV levels were low enough to be considered undetectable. After, 96 weeks, 60% of participants demonstrated HIV RNA suppression.

Nausea was the most common adverse event witnessed in a clinical trial. Serious adverse events included elevations in liver enzymes among patients also diagnosed with hepatitis C or B virus, and immune reconstitution syndrome.

The US FDA granted approval of this drug to ViiV Healthcare under fast track, priority review, and breakthrough therapy designations.

Source Credit - https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-treatment-patients-limited-treatment-options#:~:text=Today%2C%20the%20U.S.%20Food%20and,resistance%2C%20intolerance%20or%20safety%20considerations.

  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal     twitter

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More..

More News By Mateen Dalal

Microsoft investigates Teams and Outlook outage that left users disrupted

Microsoft investigates Teams and Outlook outage that left users disrupted

By Mateen Dalal

Microsoft, the U.S.-based technology frontrunner, reportedly investigating an outage that prevented thousands of customers from accessing services like Teams and Outlook. Apparently, the tech giant did not disclose the number of users that were im...

UK: Budget & basic items’ cost in supermarkets soar 20.3% in December

UK: Budget & basic items’ cost in supermarkets soar 20.3% in December

By Mateen Dalal

Britishers who rely on the budget-friendly aisles of supermarkets reportedly saw the biggest increases in food prices in the months leading up to Christmas, significantly outpacing those for luxury as well as premium brands, as per a survey. Accor...

Sun Cable shuts as $21B solar project to power S’pore hangs in balance

Sun Cable shuts as $21B solar project to power S’pore hangs in balance

By Mateen Dalal

Sun Cable, the Singapore-based solar energy company, has reportedly entered voluntary administration, despite the financial support it received from billionaire investors. The company was supposed to be working on a A$30 billion (US$21 billion) solar...