• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA approves first two-drug HIV regimen in a single pill

November 22, 2017 By Sarah Faulkner

Juluca HIV drugThe FDA yesterday approved the first two-drug regimen available in a single pill for the maintenance treatment of HIV.

The drug, Juluca, combines ViiV Healthcare‘s integrase strand transfer inhibitor and Janssen Therapeutics‘ non-nucleoside reverse transcriptase inhibitor.

The treatment is indicated for adults with HIV who are virologically suppressed on a stable anti-retroviral regimen for at least six months.

“The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care,” Deborah Waterhouse, CEO of Viiv Healthcare, said in prepared remarks.

“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first two-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”

“Today’s approval of Juluca marks a significant milestone in the treatment of HIV,” Brian Woodfall, global head of late development for Janssen’s R&D division, added.

“As the first single-pill, complete two-drug regimen, Juluca maintains the safety and efficacy of a traditional three-drug regimen without an N(t)RTI. This is exciting because it offers those living with HIV who are compliant and stably suppressed a new, simplified treatment option to consider.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: janssen, viivhealthcare

IN CASE YOU MISSED IT

  • BD stock up on Street-beating preliminary quarterly revenue numbers
  • Locate Bio lands FDA breakthrough nod for bone infection device
  • PerkinElmer to acquire Oxford Immunotec
  • Evonik buys polymers business from Durect Corp.
  • New Croatian notified body designated to European MDR

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by DrugDeliveryNow

Footer

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
Medical Tubing + Extrusion

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery News
Advertise with us
About
Contact us
Privacy
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS