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news.BioCryst Pharmaceuticals’ plasma kallikrein inhibitor BCX7353 has been given fast track designation by the US Food and Drug Administration (FDA) for the prevention of angioedema attacks in patients having hereditary angioedema (HAE).
Image: FDA grants orphan drug designation to Onspira Therapeutics’ Investigational Interleukin-1 Receptor antagonist. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
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The fast track designation gives BioCryst Pharmaceuticals the scope for frequent interactions with the FDA during development of the drug.
It also gives the opportunity for priority review for BCX7353 if backed by clinical data during its new drug application (NDA) submission.
BioCryst Pharmaceuticals president & CEO Jon Stonehouse said: “Fast Track Designation from the FDA serves as another indicator of the importance of BCX7353 to meet an unmet medical need for HAE patients in the U.S.
“We remain focused on completing the Phase 3 program and preparing for an NDA filing in the second half of 2019.”
BCX7353, which is intended to be taken orally, daily once, was generally safe and well tolerated during a phase 2 trial dubbed APeX-1.
Currently, BioCryst is carrying out the Phase 3 APeX-2 trial and also the long-term safety APeX-S clinical trial. Both the trials are assessing two dosage strengths of BCX7353 given orally once-daily as a preventive treatment to cut down the frequency of attacks in HAE patients.
The North Carolina-based company is also undertaking a proof-of-concept phase 2 clinical trial called ZENITH-1 to evaluate BCX7353 in an oral liquid formulation for the acute treatment of angioedema attacks.
The company is focused on development of novel small-molecule medicines for the treatment of both common and rare conditions.
Last month, BioCryst Pharmaceuticals said that it scrapped a previously announced merger deal with Idera Pharmaceuticals after its shareholders did not vote in favor of the transaction.
The merger was proposed in January with an aim to create a new company focused on the development and commercialization of medicines to cover more patients suffering from rare diseases.
As per the terms, each of the BioCryst shares were to be exchanged for 0.50 shares of the new company stock and each share of Idera exchanged for 0.20 shares of the new company stock.
