FDA PANEL BACKS ACCELERATED T-PA

19 June 1994

The US Food and Drug Administration's Cardiovascular & Renal Drugs Advisory Committee has unanimously recommended approval for a rapid infusion regimen for Genentech's tissue plasminogen activator product Activase (alteplase). In doing so, the panel has effectively endorsed the results of the GUSTO trial, which indicated that alteplase has arterial patency and survival advantages over its chief rival, the far cheaper streptokinase. The experimental methods used in this study have come under attack by streptokinase supporters.

The recommendations are an important step toward improving heart attack survival rates in the USA, according to Kirk Raab, Genentech's president and chief executive. "As many as 1,700 additional lives might be saved by increased use of tPA," he said. Formal FDA approval is expected to follow shortly, according to analysts, but the approval is not expected to have any significant effect on sales in the near-term as the product already has around 70% market share in the USA.

Follow-up of the patients assessed in GUSTO has also revealed that the survival benefits of accelerated tPA are maintained for one year. Each survivor of a heart attack lives on average for an additional seven to 11 years, according to cardiologists. "Based on the the life-saving benefit of accelerated Activase tPA seen in GUSTO, its cost effectiveness (about $29,000-$40,000 per year of life saved) is comparable to other widely accepted and life-saving and life-extending treatments such as cholesterol-lowering therapy, kidney dialysis, high blood pressure therapy, mammography and open heart surgery," said Sanford Schwartz of the Leonard Davis Institute of Health Economics.

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



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight