Significant, clinically meaningful reduction of HAE attacks

2019-05-07T12:56:15+01:00November 16, 2018|HAEi News, Uncategorized|

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

2019-05-07T12:56:15+01:00November 13, 2018|HAEi News, Uncategorized|

“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,” said Andrew Crockett, CEO of KalVista Pharmaceuticals, Inc. “Our first step [...]

Firazyr approved for HAE attacks in Japan

2019-05-07T12:56:15+01:00September 21, 2018|HAEi News, Uncategorized|

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 [...]

Agreement with PMDA on Clinical Trial and Regulatory Requirements

2019-05-07T12:56:15+01:00June 25, 2018|HAEi News, Uncategorized|

BioCryst Pharmaceuticals, Inc. has reached agreement on the design of a Phase 3 trial and regulatory requirements for marketing authorization of BCX7353 for HAE with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The Phase 3 trial design agreed upon for Japan, APeX-J, is a randomized, placebo-controlled double-blind trial of 24 weeks duration with [...]