Bjerre

About Steen Bjerre

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So far Steen Bjerre has created 206 blog entries.

Favorable conclusion from study of acute HAE therapies

2018-12-07T09:52:24+00:00

A new study examines and compares re-dosing rates inter alia for human C1 esterase inhibitor in recombinant form (Ruconest®) and plasma-derived forms (Berinert®, Cinryze®) to icatibant (Firazyr®) in seven individual patients at risk of HAE attacks. A total of 69 attacks were recorded.  The study was led by Professor Dr Marcus Magerl of the Department [...]

European approval for subcutaneous HAE medication

2018-11-30T10:13:01+00:00

The European Commission (EC) has granted Shire plc Marketing Authorisation for TAKHZYRO™ (as Lanadelumab) subcutaneous injection for routine prevention of recurrent attacks of HAE in patients aged 12 years and older. TAKHZYRO is a first-of-its-kind fully human monoclonal antibody (mAb) that inhibits the activity of plasma kallikrein, an enzyme which is uncontrolled in people with [...]

Complete Results of Study Evaluating Preventive Treatment

2018-11-27T22:31:18+00:00

The Journal of the American Medical Association (JAMA) publishes the complete results from the Phase 3 HELP Study™, a randomised, placebo-controlled trial evaluating the efficacy and safety of subcutaneously administered Lanadelumab versus placebo over 26 weeks in 125 patients 12 years of age or older with HAE. The HELP Study™ is the largest randomised controlled [...]

Oral formulation rapidly absorbed

2018-11-16T22:54:27+00:00

BioCryst Pharmaceuticals, Inc. presents data showing that an oral formulation of BCX7353 was rapidly absorbed and exhibited a long half-life, two important characteristics of desired new acute treatments for HAE attacks. In the trial, the pharmacokinetic (PK) and kallikrein inhibition profiles of BCX7353 were evaluated for 24 hours post-dose in six subjects with HAE Type I or II [...]

Significant, clinically meaningful reduction of HAE attacks

2018-11-16T08:26:27+00:00

Shire plc has announced additional data from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study, evaluating the efficacy and safety of subcutaneously administered Lanadelumab in HAE. Data shows that patients treated with Lanadelumab 300 mg every two weeks experienced significantly fewer HAE attacks, were less likely to have moderate or severe attacks or use rescue medication [...]

More aggressive development plan for HAE candidate

2018-11-13T16:47:49+00:00

“Thanks to our recent equity financing and the exciting Phase 1 data from our HAE candidate KVD900, we are pleased to announce that we are building on these successes with a more aggressive development plan for KVD900, to potentially accelerate our time to market,” says Andrew Crockett, CEO of KalVista Pharmaceuticals, Inc. “Our first step [...]

CHMP Recommends EU Marketing Authorisation of Lanadelumab

2018-10-25T13:29:14+00:00

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorisation of Lanadelumab injection for routine prevention of recurrent attacks of HAE in patients aged 12 years and older. If approved, Lanadelumab will be a first-of-its-kind, fully human monoclonal antibody (mAb) available [...]

“Global Perspectives” #3/2018 out now

2018-09-26T18:05:08+00:00

Dear HAE friends, We have just released the third 2018 issue of the HAEi magazine ’Global Perspectives’. Once more we give you a comprehensive insight into a great number of HAE related things going on around the globe. Among the topics in the magazine you will find an article on the additions to our Regional [...]

Firazyr approved for HAE attacks in Japan

2018-09-21T08:47:05+00:00

The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted manufacturing and marketing authorization for Firazyr for the acute treatment of HAE attacks in adult patients. “As a long-term partner to the HAE community, we continually strive to bring treatments to those living with HAE around the world,” said Andreas Busch, Ph.D., Executive [...]

Health Canada authorizes TAKHZYRO

2018-09-20T13:40:57+00:00

Shire plc and Shire Pharma Canada ULC (Shire Canada) announces that following priority review, Health Canada has authorized TAKHZYRO (lanadelumab injection) for routine prevention of attacks of HAE in adolescents and adults (12 years of age and older). "The burden HAE patients and their families face every day can’t be ignored,” said Jacquie Badiou, President, HAE Canada. “Our [...]