EMEA accepts Jerini's HAE drug MAA
German pharmaceutical group Jerini says that its Marketing Authorization Application, which requests approval for its drug icatibant as a treatment for hereditary angioedema, has been accepted by the European Medicines Agency (EMEA).The drug, which is a synthetic peptidomimetic blocks the B2 receptor, thereby functioning as an antagonist for the hormone bradykinin, which has been linked to HAE attacks.
In addition, the agency's Committee for Medicinal Products for Human Use (CHMP) has earmarked the product for accelerated assessment, shortening the review period from 210 to 150 days, meaning that the it could issue its opinion by the first quarter next year.
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