Current Treatment Strategies for Urticaria
Two experts review their treatment strategies for addressing urticaria in their patients.
Angioedema
Berotralstat NDA for Hereditary Angioedema Prophylaxis Submitted to FDA
The New Drug Application for berotralstat for the prevention of hereditary angioedema attacks has been submitted to the Food and Drug Administration.
FDA Requests Another Clinical Trial for Ruconest in HAE Prophylaxis
The Company filed the sBLA last November following FDA feedback on two completed Phase 2 trials of Ruconest for prophylaxis of HAE attacks.
First-of-its-Kind Therapy Approved to Prevent Hereditary Angioedema Attacks
The approval was based on data from 4 clinical trials, including the 26-week Phase 3 HELP (Hereditary Angioedema Long-Term Prophylaxis) study that enrolled 125 patients with HAE aged ≥12 years.
Single-Administration Treatment for Hereditary Angioedema Gets Orphan Drug Status
ADVM-053 is being developed as a single‑administration treatment that could potentially provide sustained levels of the C1 esterase inhibitor protein, which may prevent breakthrough angioedema attacks.
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