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Published on 17 January 2008

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Marvel withdraws EMEA applications

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Marvel LifeSciences has formally notified the European Medicines Agency (EMEA) that it has decided to withdraw its applications for a centralised marketing authorisation for three diabetes treatments.

The decision relates to Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel, which were expected to be used to treat patients with diabetes mellitus.

The applications were made as applications for similar biological medicinal products, and claimed that the medicines are biologically similar to Eli Lilly’s Humulin, which is already authorised in the European Union.

At the time the applications were withdrawn, they were under review by the agency’s Committee for Medicinal Products for Human Use (CHMP).

The company stated that it had withdrawn the three applications after the CHMP said it would not grant the firm a further extension to respond to a list of questions it had about the drugs.

The CHMP had already given the firm an extra three months to provide the information.

The EMEA said it will publish more information about the state of the scientific assessment on the three treatments at the time of their withdrawal on its website.

Copyright © PA Business 2008

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