Second Immunomedics Product Approved By EU
Immunomedics has received its first approval from the EuropeanCommittee for Proprietary Medicinal Products for LeukoScan, its diagnostic for the detection of osteomyelitis, particularly in diabetic patients with foot ulcers. The approval covers all 15 member countries of the European Union, and follows notification of LeukoScan's approvable status last year (Marketletter October 28, 1996). Immunomedics is currently in negotiations with potential distribution partners.
It is the second Immunomedics' product to reach this stage, following CEA-Scan, its colorectal imaging agent, which is currently being launched in the USA and in European markets.
Immunomedics filed a Biologics License Application with the US Food and Drug Administration for approval of LeukoScan earlier this year (Marketletter January 6). The application is currently under review for the same indications as in Europe, plus an additional indication for use in patients with acute, atypical appendicitis.
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