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Dyax withdraws its European application for hereditary angioedema treatment Kalbitor

US biotech unable to provide sufficient data to support its hereditary angioedema drug for EU approval

US biotech Dyax has withdrawn its European marketing authorisation application for its hereditary angioedema (HAE) drug Kalbitor (ecallantide).

The decision came after the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) indicated Dyax had not provided sufficient evidence to demonstrate a positive benefit-risk balance for Kalbitor.

Dyax said it would consider resubmitting Kalbitor to the EMA once the results of an ongoing bioequivalence study using a high-strength formulation of the drug become available.

Dyax said it will press on with marketing applications and regulatory approvals in other international territories, including Australia, the Middle East and Latin America.

The biotech has already won for Kalbitor in the US, where the drug is approved to treat acute attacks of (HAE) in patients aged 16 years and over.

15th November 2011

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