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.
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