Viragen's Multiferon approved in Sweden

US drugmaker Viragen says that the Swedish Medical Products Agency has approved its drug Multiferon (multi-subtype, natural human alpha interferon) for the first-line adjuvant treatment of high-risk (Stages IIb-III) malignant melanoma following dacarbazine after surgical removal of tumors. The firm will officially launch this new malignant melanoma indication this month.

The approval was based on clinical trial data that demonstrated a statistically-significant advantage over untreated controls in terms of survival-without-distant-metastasis and overall survival.

Currently-used treatment guidelines for high-risk malignant melanoma in Sweden advise prescribing recombinant alpha interferon, following resection, for up to 18 months, sometimes in a high-dose regimen. By comparison, two doses of dacarbazine followed by low-dose Multiferon for six months represents a significant reduction in total treatment time and cost, the firm noted.