About Steen Bjerre

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So far Steen Bjerre has created 134 blog entries.

The Lancet publicizes RUCONEST® prophylactic data


The weekly peer-reviewed general medical journal The Lancet has published data from a Phase II, double-blind, placebo-controlled, randomized clinical trial (NCT02247739) evaluating the efficacy and safety of RUCONEST (C1 esterase inhibitor [recombinant]) for the prevention of HAE attacks. As previously reported, in a study with 32 patients RUCONEST® 50 IU/kg (max 4200 IU) demonstrated a [...]

FDA Orphan-Drug Exclusivity for HAEGARDA


The U.S. Food and Drug Administration (FDA) has granted CSL Behring seven years of orphan-drug exclusivity for HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous treatment option for prevention of HAE attacks. HAEGARDA was approved by the FDA on 22 June 2017 for routine prophylaxis to prevent HAE attacks in adolescent and [...]

Second 2017 edition of “Global Perspectives” out now


We are excited to inform you that the second 2017 edition of “Global Perspectives” – the HAEi magazine – is out today. Among many other topics you will find: the story of Patricia Karani, the new HAEi Regional Patient Advocate for Sub-Sahara Africa highlights from the 10th C1-INH workshop in Budapest, Hungary news from our Regional Patient [...]

Regional Patient Advocate for sub-Sahara Africa


Early 2016 HAEi appointed five Regional Patient Advocates, dividing a large portion of the world between them. As per 1 July 2017, they are joined by Patricia Karani who will be focusing on the sub-Sahara part of the African continent. Patricia Karani was born in Nairobi, Kenya where she is currently residing. She holds a [...]

FDA approves first subcutaneous C1 Esterase Inhibitor


The U.S. Food and Drug Administration has approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent HAE attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received. "The approval of Haegarda provides [...]

Thousands helped raise HAE awareness step by step


On and around hae day :-) 2017 a group of HAE patients, caregivers, doctors and people from HAE organizations walked four stages of the Camino in northern Spain. Many more would have liked to take part in this walk but were not able to do so. Therefore HAEi arranged the HAE Global Walk 2017, allowing [...]

Positive Results From the Second Interim Analysis


BioCryst Pharmaceuticals, Inc. has announced results from a second interim analysis of its Phase 2 APeX-1 clinical trial in HAE. APeX-1 is a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once-daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of [...]

Attune Announces Positive Data from Pre-Clinical Studies


  Attune Pharmaceuticals announces positive results from preclinical safety studies evaluating ATN-249, a novel orally administered plasma kallikrein inhibitor for the treatment of HAE. The strong safety, high potency, and high selectivity results suggest a wide therapeutic window with once-daily dosing potential of ATN-249. In the preclinical toxicology and safety pharmacology studies, ATN-249 was generally [...]

Lanadelumab Reduces HAE Monthly Attack Rate by 87 %


Shire plc announces positive topline Phase 3 results for the HELP study, a global, multi-center, randomized, double-blind placebo-controlled parallel group trial that evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo over 26 weeks in patients 12 years of age or older with HAE. Lanadelumab is an investigational treatment being evaluated for the [...]