Please login to the form below

Not currently logged in
Email:
Password:

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US biotech Dyax has withdrawn its European marketing authorisation application for its hereditary angioedema (HAE) drug Kalbitor (ecallantide).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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Atlantis Healthcare

Atlantis Healthcare is a global leader in optimising patient self-management. Established in 1996, we design, develop and implement scalable solutions...

Latest intelligence

segmentation_pie_thumb.jpg
If you’re not thinking segmentation, you’re not thinking
Having a background in market research I’ve been lucky to work on a number of customer segmentations in my time but working in creative communications it is still too rare...
Improving Outcomes in the Treatment of Opioid Dependence Highlights Report
The 16th annual ‘Improving Outcomes in the Treatment of Opioid Dependence’ (IOTOD)conference took place at the Hilton Madrid Airport hotel on 15–16 May 2018....
Londonvelophobia (fear of cycling in London) – debunked
...

Infographics