Today is 1 April 2020 – and that marks the beginning of this year’s HAE Global Walk. Due to coronavirus COVID-19, the population in a large number of countries around the world experience harsh limitations to everyday life. Nevertheless, we hope that many people will find it possible to take part in our 2020 HAE [...]
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) submission for approval of oral, once-daily berotralstat (BCX7353) for the prevention of HAE attacks. With this validation, the EMA has begun their formal review of the MAA under the centralized procedure for all member states of the European Union, Norway, Iceland, and Liechtenstein. [...]
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended approval of Ruconest for the treatment of acute angioedema attacks in children with HAE. This marketing authorization would expand the age range of Pharming Group N.V.‘s lead product, a recombinant analogue of the human C1 esterase inhibitor produced [...]
Dear HAEi Friends, The health and well-being of our global community is HAEi’s top priority. With that in mind, we asked our medical experts to provide their best thinking regarding the COVID-19 virus health risks that might be faced by people who have hereditary angioedema and other forms of recurrent angioedema. COVID-19 is a [...]
Dear HAEi Friends, On behalf of the HAEi Board of Directors and the entire HAEi team, I would like to extend our heartfelt wishes for the health and safety of you and your families as you deal with COVID 19 Coronavirus pandemic. HAEi cares deeply about the health and well-being of the wonderful people [...]
The health and well-being of everyone in the HAE community is of paramount importance to us! As communicated before, HAE International has been carefully monitoring the developing situation regarding COVID-19 (novel coronavirus). HAEi leadership has been meeting on a daily basis to carefully assess the evolving situation and has determined that we cannot ensure the health and safety of [...]
New data from the APeX-2 trial shows that 150 mg of oral, once-daily berotralstat (BCX7353) for prophylaxis of HAE attacks reduced patients’ monthly use of standard of care (SoC) on-demand medicine by 53.6 percent compared to placebo, and reduced the number of HAE attacks requiring acute SoC treatment by 49.2 percent compared to placebo. Additional [...]
The HAE International team continues to meet around the clock and carefully monitor the developing global situation regarding the COVID-19 (novel coronavirus), which now includes the declaration of a pandemic by the World Health Organization. We understand and share the concerns we are hearing from conference participants regarding travel and public gatherings. HAEi fully understands [...]
The US Food and Drug Administration (FDA) has approved Pharming Group N.V.’s Prior Approval Supplement to add the new Netherlands production facility of starting material to the Biologics License Application (BLA) to support its lead product Ruconest. With the addition of this new facility for US supplies as well, Pharming can continue to expand sales [...]
At the release of the financial results for the fiscal third quarter ending 31 January 2020 KalVista Pharmaceuticals, Inc. CEO Andrew Crockett said the ‘work to bring multiple best-in-class oral therapies to patients with HAE is advancing well’: “First, we look forward to delivering data in the second quarter of this year from our Phase 2 [...]
