1. Scrip
  2. >>Business

Gilead’s Marketing Of Descovy For HIV Prevention Should Not Suggest Superiority To Truvada

 
• By Sue Sutter

US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.

stop-gesture
Gilead’s positioning of Descovy as a safer option for PrEP faced resistance at an FDA advisory committee review. • Source: Shutterstock

Gilead Sciences Inc. has emphasized the renal and bone safety benefits of Descovy (emtricitabine/tenofovir alafenamide or FTC/TAF) relative to Truvada (emtricitabine/tenofovir disoproxil fumarate or FTC/TDF) as it works to convert patients ahead of generic competition to the older HIV fixed-dose combination therapy in 2020.

However, those efforts hit strong resistance at a US Food and Drug Administration advisory committee review of a pre-exposure

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 Business

GSK Pays $1.8bn For Phase III-Ready MASH Contender

 
• By Andrew McConaghie

The acquisition of Boston Pharma’s once-a-month FGF21 analog adds to GSK’s liver disease portfolio.

Lundbeck Lifted By Leap In Migraine Therapy Sales

 
• By Kevin Grogan

Vyepti revenues rise by nearly 70% in the first quarter.

Finance Watch: Funding Alternatives Become The Norm In Tough Public Markets

 
• By Mandy Jackson

Public Company Edition: With fewer follow-on offerings, drug developers are pursuing other options. Axsome accessed up to $570m in debt, Evolus obtained $250m in a new credit facility and Abeona raised $155m from a PRV sale, but Apimeds was able to execute a small $13.5m IPO.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 
• By Andrew McConaghie

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.

More from Scrip

Finance Watch: Funding Alternatives Become The Norm In Tough Public Markets

 
• By Mandy Jackson

Public Company Edition: With fewer follow-on offerings, drug developers are pursuing other options. Axsome accessed up to $570m in debt, Evolus obtained $250m in a new credit facility and Abeona raised $155m from a PRV sale, but Apimeds was able to execute a small $13.5m IPO.

iTeos/GSK To Terminate Collaboration After TIGIT Trials Flop

 
• By Alaric DeArment

Belrestotug is the latest anti-TIGIT candidate to fail to meet expectations. iTeos said it will pursue strategic alternatives.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 
• By Andrew McConaghie

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.