Actelion's Tracleer launched in USA, with narrower label in Canada

5 December 2001

Switzerland's Actelion has launched its orally-active endothelinreceptor antagonist Tracleer (bosentan) for the treatment of pulmonary arterial hypertension in the USA, its first market. PAH is a chronic, life-threatening disorder that can severely compromise the function of the lungs and heart. Tracleer is the first orally-active treatment for PAH, which is thought to affect around 100,000 patients in the USA and Europe, to reach the market.

Tracleer is available in bottles of 60 tablets, in strengths of 62.5mg and 125mg, and the approved dose is 125mg twice-daily.

The product is distributed through a limited group of four specialty pharmacy operators, namely Caremark, Gentiva Health Services, Nova Factor and Procare Pharmacy, and can only be prescribed by physicians participating in the Tracleer Access Program, a measure designed to ensure use of the drug in appropriate patients. Around 11% of patients taking the endothelin antagonist exhibit reversible increases in liver enzymes, so recipients require monthly liver monitoring. Moreover, Tracleer can cause birth defects so should not be taken by women who are pregnant or may become pregnant, while monthly pregnancy tests are a condition of use for all other women of childbearing potential.

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 account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • 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



Company News Directory



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight