19:55 , Oct 13, 2017 |  BioCentury  |  Regulation

Expanding the HAE tool kit

Despite an increasingly crowded market, hereditary angioedema patients who attended FDA’s Patient-Focused Drug Development meeting said there remains room for improvement in dosing convenience and reducing attack frequency. Two subcutaneous prophylactics that have completed Phase...
18:56 , Jun 30, 2017 |  BC Week In Review  |  Clinical News

FDA approves CSL's Haegarda for HAE

FDA approved Haegarda (subcutaneous C1-INH, CSL830) from CSL Ltd. (ASX:CSL) to prevent hereditary angioedema (HAE) in adolescent and adult patients. The agency said Haegarda, which has Orphan Drug status, is the first subcutaneous complement 1...
23:46 , Jun 22, 2017 |  BC Extra  |  Company News

FDA approves CSL's Haegarda for HAE

FDA approved Haegarda (CSL830) from CSL Ltd. (ASX:CSL) to prevent hereditary angioedema in adolescent and adult patients. The agency said Haegarda, which has Orphan Drug status, is the first subcutaneous complement 1 (C1) esterase inhibitor...
00:53 , Apr 12, 2017 |  BC Week In Review  |  Clinical News

CSL830: Ph III COMPACT data

The double-blind, crossover, international Phase III COMPACT trial in 90 Type I or II HAE patients showed that twice-weekly 40 and 60 IU/kg subcutaneous CSL830 each met the primary endpoint of reducing the mean number...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Subcutaneous C1-INH regulatory update

FDA accepted for review a BLA from CSL for CSL830 to prevent hereditary angioedema (HAE) attacks. The therapy is a low-volume, subcutaneous complement 1 (C1) esterase inhibitor. CSL markets an IV version of a...
07:00 , Aug 30, 2016 |  BC Extra  |  Company News

FDA reviewing CSL's CSL830 for HAE prophylaxis

FDA accepted for review a BLA from CSL Ltd. (ASX:CSL) for CSL830 ( subcutaneous C1-INH) to prevent hereditary angioedema (HAE) attacks. The therapy is a low-volume, subcutaneous complement 1 (C1) esterase inhibitor. CSL markets an...
07:00 , Jul 25, 2016 |  BC Week In Review  |  Clinical News

Berinert regulatory update

CSL said FDA approved Berinert to treat acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in patients ages <12. The plasma-derived human complement 1 (C1) esterase inhibitor is now approved for all...
00:23 , Jul 18, 2014 |  BC Extra  |  Company News

FDA approves Ruconest from Pharming, Salix

Pharming Group N.V. (Euronext:PHARM) jumped EUR 0.08 (17%) to EUR 0.54 on Thursday after FDA approved a resubmitted BLA for Ruconest conestat alfa to treat acute angioedema attacks in adult and adolescent patients with hereditary...
08:00 , Feb 27, 2014 |  BC Innovations  |  Targets & Mechanisms

The XII factor

Factor XII sits atop one branch of the clotting cascade but has not been pursued for treating and preventing thrombosis because it was seen as a minor player in blood coagulation. Now, a group from...
08:00 , Feb 24, 2014 |  BC Week In Review  |  Clinical News

Subcutaneous C1-INH: Phase III started

CSL began the double-blind, crossover, U.S. Phase III COMPACT trial to evaluate subcutaneous C1-INH twice weekly in about 80 patients with HAE types I or II who have frequent attacks. Patients will receive higher-volume placebo...