Contract notice: Tender for the supply of C1 esterase
applications for recombinant C1 esterase
inhibitors referencing RUCONEST submitted under section 351(k) of the Public Health Service Act under the framework established by the Biologics Price Competition and Innovation Act of 2009.
inhibitor deficiency is a hereditary condition where reduced activity of C1 inhibitor leads to episodic angioedema, often triggered by stress, trauma and surgery.
The license provides ViroPharma with exclusivity to C1 esterase
inhibition and to the hereditary angioedema (HAE) indication, along with three additional orphan indications, Halozyme added.
Since circumstances strongly suggested the diagnosis of familial angio-oedema, complement function was investigated, which confirmed a low C4 level and deficiency of C1 esterase
in all 3.
The complement protein C1 esterase
inhibitor (C1-INH) is an acute phase protein , the plasma level of which can possibly increase in acute phase responses.
The condition is caused by a genetic deficiency of C1 esterase
inhibitor (C1-INH), a naturally occurring molecule that inhibits kallikrein and other serine proteases in the blood.
Hereditary angioedema is caused by an absolute deficiency or the functional inactivity of C1 esterase
inhibitor in plasma.
NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST([R]) (recombinant human C1 esterase
inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.
RUCONESTA (conestat alfa) is a recombinant human C1 esterase
inhibitor approved for the treatment of angioedema attacks in patients with HAE in the US, Israel, all 28 EU countries plus Norway, Iceland and Liechtenstein.
CINCINNATI -- In response to reports of a shortage of one C1 esterase
inhibitor (C1-INH) product on the market, BioRx affirmed today that its supply of Berinert[R] (C1 esterase
inhibitor, human) remains strong and can immediately accommodate increased demand.
HAE is a rare genetic disorder caused by a deficiency of C1 Esterase