The committee will now recommend that the European Commission grant marketing authorization for Icatibant, which is normally issued within 67 days from adoption of the Committee for Medicinal Products for Human Use (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 hereditary angioedema (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.
Jens Schneider-Mergener, CEO of Jerini, said: “Icatibant will claimed to 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 authorization.”