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CHMP and FDA disagree on angioedema drug

Berlin-based Jerini AG announced today that the company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for icatibant in the treatment of acute attacks of hereditary angioedema (HAE).

The committee will now recommend that the European Commission grant marketing authorisation for Icatibant, which is normally issued within 67 days from adoption of the CHMP opinion.

In addition, Jerini has received a not approvable letter from the FDA for its New Drug Application (NDA) for Icatibant in the treatment of HAE. The company is reviewing the contents of the letter and plans to meet with the FDA at the earliest opportunity to address the agency’s concerns.

“The CHMP’s positive opinion is outstanding news for Jerini and HAE patients in Europe. Icatibant will be the first product to be approved in all European countries for the acute treatment of HAE, and our sales and marketing teams are in place and ready to launch following the European Commission’s marketing authorisation,” said Jens Schneider-Mergener, CEO of Jerini.

“It is extremely unfortunate that patients in the US will not have access to icatibant in order to treat this debilitating and potentially life-threatening disease as quickly as in Europe. We intend to work closely with the FDA to obtain icatibant’s approval as soon as possible.”

“It’s very good news that the CHMP has reacted positively to icatibant. We currently have a very limited range of medicines with which to treat this extremely unpleasant condition and there is a real need for new developments. Icatibant has a completely different mechanism of action to existing treatments and will be a most welcome addition to our formulary. Since icatibant is delivered by subcutaneous injection it represents a big step in improving access to treatment for patients,” said Dr Hilary Longhurst, consultant immunologist in the Department of Immunology, Barts and The London NHS Trust, London.

Jerini AG

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