QLT says that the US Food and Drug Administration has granted final approval for the company’s acne gel, Aczone (dapsone), just days after Astellas ended its partnership for the product with the company [[08/07/05e]].
However, it looks as if Astellas’ reasons for dropping the collaboration – namely because it felt the FDA would give Aczone a limited label – as potential patients will need to be screened for a certain type of anaemia before they can begin treatment, because of a specific enzyme deficiency. Patients with the enzyme deficiency will need to be monitored with regular blood counts. In clinical trials, 1.4% of about 3,500 patients had this disorder, which the company says is consistent with the incidence in the general North American population, although certain populations are thought to be more predisposed to the condition. QLT will carry out a post-approval Phase IV study in 50 acne patients who have the enzyme deficiency and follow them for six months, and expects to file its findings with the FDA for label re-evaluation.
Paul Hastings, president and chief executive officer of QLT, said: “Aczone represents an important clinical advance in dermatology, has demonstrated safety and efficacy in over 4,000 patients, and is an important first step for QLT to market our own products and establish our own commercial organisation.” The firm’s share price climbed by 5% on the Nasdaq Stock Exchange on Friday