מתוך medicontext.co.il
NEW YORK (Reuters Health) – Novartis Pharmaceuticals said on Thursday that the US Food and Drug Administration (FDA) has approved the company's pimecrolimus (Elidel Cream 1%) as a treatment for atopic dermatitis.
The product will be "the first non-steroid prescription cream for mild to moderate atopic dermatitis in patients aged 2 years and older," according a statement for Novartis. Pimecrolimus is indicated for short-term and intermittent long-term treatment of patients who do not respond well to or experience side effects with conventional treatments, the firm said
Novartis plans to launch Elidel in the US in early 2002. The company has also filed marketing applications for the product in Demark, Switzerland and Canada.
Novartis said it intends to study the product in infants "where the need for new therapeutic alteratives is significant."
Separately, the firm said on Thursday that it had received an approvable letter from the FDA for its antiepileptic drug oxcarbazepine (Trileptal) for use as monotherapy in treating partial seizures in children as young as 4 years old.
Trileptal is currently approved as monotherapy and adjunctive therapy for adults and as an adjunctive therapy for children between the ages of 4 and 16 years.
Five other antiepileptic drugs are approved as monotherapies for children, but they can have serious side effects or require frequent blood tests or complex dosing and titration schedules, the firm claims.
According to Novartis, Trileptal has a favorable side-effect profile, with no black box warning and no links to aplastic anemia, agranulocytosis, hepatotoxicity or pancreatitis. Further, no monitoring of liver functions and blood counts is required for Trileptal patients, Novartis said.
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