NDA Filed For New Soft-Gel Saquinavir
Hoffmann-La Roche has filed a New Drug Application with the US Food andDrug Administration for clearance to market its protease inhibitor Fortovase (saquinavir), a new soft-gel capsule formulation of its already-marketed Invirase, to be used in combination with antiretroviral agents for the treatment of HIV.
Fortovase has a three-to-four-times greater bioavailability than the current formulation of saquinavir, according to the company, which has included data from three studies in its NDA dossier.
Data from a trial comparing Fortovase and Invirase (plus two nucleoside analogs in both arms) were presented at the 37th Intersciences Conference on Antimicrobial Agents and Chemotherapy in Toronto, Canada.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze