1. Scrip
  2. >>R&D
  3. >>Clinical Trials

High Efficacy Halts ViiV HIV Prevention Study Early

ViiV Hopes Faster Cabotegravir Approval Will Be The Result

 
• By Sten Stovall

Prospects have improved for ViiV’s long-acting, injectable cabotegravir to be approved early for HIV prevention after a Phase III trial was stopped early due to efficacy.

HIV_Blood_Test
HPTN 083 compared injectable long-acting cabotegravir with daily Truvada pills. • Source: Shutterstock

ViiV Healthcare plans to enter talks with the US Food and Drug Administration and other agencies to see if the data from a Phase III trial that has just been stopped early because of high efficacy will be enough for a regulatory submission of its long-acting, injectable investigational therapy, cabotegravir, as a preventative treatment for HIV.

Cabotegravir is yet to be approved for the treatment or prevention of HIV as a single agent by regulatory authorities...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Altimmune’s Phase IIb MASH Data Send Share Price Plunging

 
• By Joseph Haas

Altimmune’s stock price did not recover on June 27, after a 57% dip the day before, despite efforts to position pemvidutide as both resolving MASH and offering weight loss.

What Incyte Investors Expect From New CEO Bill Meury

 
• By Andrew McConaghie

Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
• By Kevin Grogan

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
• By Aakash Babu

The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.

More from R&D

GSK, Bharat On Shigella Vaccine Phase II Data Timelines, Malaria Vaccine Price Halving

 
• By Vibha Ravi

GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut

Pfizer’s Hympavzi Poised For Broader Hemophilia Label

 
• By Alaric DeArment

The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.

Pharma Growth And Biotech Squeeze Will Shape Sector To 2030, Evaluate Forecasts

 
• By Andrew McConaghie

Evaluate’s five-year forecast sees steady growth for big pharma despite recent political turmoil but tougher times ahead for the ‘have nots’ of biotech.