Roche seeks OK for juvenile Actemra use

Roche is asking regulators in the U.S. and Europe for approval to market its arthritis treatment Actemra/RoActemra for a rare form of the disease in children. The malady--systemic Juvenile Idiopathic Arthritis--has the worst long-term prognosis of any childhood arthritis, causing some two-thirds of all deaths in children from arthritis, Roche says in a statement. There are currently no drugs approved specifically for it.

If Roche gets the regulatory OK, it would further bolster the potential peak sales of Actemra, which at least one analyst dubs "Roche's most important drug launch for this decade." Kepler Capital Markets analyst Martin Voegtli expects the drug to peak at 4.6 billion francs (some $4.8 billion), with something less than 500 million francs ($521 million) coming from this juvenile arthritis use. "[It] adds nicely to the commercial potential of Actemra," Voegtli tells Reuters.

The approval application is based on the TENDER study, released in June, which showed that, after three months of treatment with the drug, 85 percent of patients showed 30 percent improvement in symptoms, compared with 24 percent of those treated with placebo.

- see the release from Roche
- read the news from Reuters