rotopic, the topical formulation of Astellas’ tacrolimus, has been launched in Europe for a new indication – as maintenance treatment to prevent flares and prolong flare-free intervals in adults and children aged two and over with moderate to severe atopic eczema.
Announced at the International Congress of Dermatology in Prague, the new indication is a major milestone for the Japanese company. Protopic’s licence was previously limited to acute treatment of disease flares in eczema patients intolerant of, or unresponsive to, conventional therapies such as topical steroids.
Under the new indication, treatment with Protopic is restricted to patients with frequent flares. But there is potentially a major opportunity for Astellas in a market where there are few options for patients and professionals. In future the company hopes to extend the new indication in Canada and possibly parts of Central and South America.
Protopic’s new indication is based on results of CONTROL, two Phase III studies conducted in 524 adults and children in 13 European countries. After one year, three times more patients receiving twice-weekly maintenance treatment with Protopic were flare-free compared to patients receiving the treatment in a flare-only regimen.
Despite these results, the company could, at least in the short term, encounter some resistance. Anti-inflammatory drugs have previously been reserved for skin with active eczema flares. Professionals may worry about treating apparently normal skin, while purchasers may fear potential cost implications, especially given the availability of generic topical steroids.
Commenting in Prague, an Astellas spokesman said: “We recognise that we need to inform general dermatologists and family doctors., so we are involved in educational initiatives at both European and national level. He added that "cost-effectiveness data are already available for twice-weekly Protopic in adults and will soon be published for children.” By Sue Lyon in Prague