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DNase gaim FDA panel's approval Genentech's DNase came a step closer to

becoming the first new cystic fibrosis therapy in

MARKET NEWS

30 years after an FDA advisory panel unanimously recommended the product's approval. If DNase [Pulmozyme~, dornase alfa] is cleared by the FDA, securities analysts are forecasting an annual patient cost of $USIO 000. Based on this figure, the market could be worth $300-495 million by 1998, reports the Wall Street Journal [6 Aug). This market value would increase dramatically if Genentech gained a broader indication for DNase, e.g. chronic bronchitis.

Rapid progns DNase development has been rapid, moving

from the research lab to regulatory hearings in just 5 years, compared with a typical 8 years, says the Wall Street Journal [10 Aug). In addition, there was only a 5-month delay between submission and review of the registration application. This reflects FDA Commissioner David Kessler's championing of fast approvals for treatments for fatal diseases.

Not a replacement for routine dlerapy DNase will not replace antibacterials, anti­

asthmatics or physiotherapy. The product is a recombinant copy of a human enzyme which breaks down DNA present in abnormal quantities in lung secretions of patients with cystic fibrosis. This makes the secretions less viscous, improving lung function and decreasing the incidence of respiratory infections. The recommended dose is 2.5mg daily administered in an aerosol form. This dosage may be increased if studies show that twice-daily therapy benefits older or sicker patients.

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