Angioedema News and Research

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Angioedema is the rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues. It is very similar to urticaria, but urticaria, commonly known as hives, occurs in the upper dermis.

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings the number of countries to 28 (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.

28 May 2010

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

Final data from Open-Label studies of Cinryze in patients with HAE now available

ViroPharma Incorporated today announced the availability of final data from Open-Label studies of Cinryze (C1 Esterase Inhibitor [Human]) in preventing and treating attacks of hereditary angioedema on the U.S. National Institutes of Health's online clinical trial registry, www.clinicaltrials.gov.

18 May 2010

ACAAI, AGA Institute announce innovative initiative to raise awareness of HAE

The American College of Allergy, Asthma and Immunology and the American Gastroenterological Association Institute today announced an innovative initiative called "HAE: Learn About It, Talk About It," at Digestive Disease Week® 2010.

4 May 2010

TB Alliance, AstraZeneca sign research collaboration agreement to develop drugs against tuberculosis

The Global Alliance for TB Drug Development and AstraZeneca announced today at the 2010 BIO International Convention that they have entered into a research collaboration agreement to accelerate the discovery, development and clinical use of drugs against tuberculosis, including drug resistant strains of the disease.

4 May 2010

New data on Cimzia for Crohn’s Disease treatment to be demonstrated at DDW 2010

Studies and analyses of the Crohn’s Disease (CD) treatment Cimzia® (certolizumab pegol) demonstrating new data will be exhibited at Digestive Disease Week (DDW) 2010, taking place in New Orleans from May 1-5, 2010.

30 Apr 2010

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

ViroPharma Incorporated today announced that it has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze (C1 esterase inhibitor [human)] in 24 adolescents and adult subjects with hereditary angioedema.

27 Apr 2010

FDA approves Novartis Pharmaceuticals' Zortress for preventing rejection of kidney transplants

The US Food and Drug Administration (FDA) has approved Zortress® (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids.

22 Apr 2010

CSL Behring calls for grant requests through LEAD program

CSL Behring, a global leader in the plasma protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.

13 Apr 2010

Economic burden associated with HAE treatment: First-ever comprehensive examination

Dyax Corp. announced the publication of a first-ever comprehensive examination of the economic burden associated with the treatment of acute attacks and chronic management of hereditary angioedema (HAE). The results, published today in the Annals of Allergy, Asthma, and Immunology, bring to light the substantial direct and indirect medical costs of the disease on patients, payers and society. The economic study is one component of a larger survey-based Burden of Illness (BOI) study which assessed both the economic and humanistic burden of HAE.

5 Apr 2010

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

ViroPharma Incorporated today announced that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze™ (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age with hereditary angioedema.

31 Mar 2010

Dyax to use proceeds of public offering for commercialization and distribution activities of KALBITOR

Dyax Corp. today announced the pricing of an underwritten public offering of 17,000,000 shares of its common stock at a price to the public of $3.25 per share. The gross proceeds from the sale of shares, after underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $51.8 million. The offering is expected to close on or about March 30, 2010, subject to customary closing conditions.

26 Mar 2010

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

ViroPharma Incorporated today announced that the European Medicines Agency (EMA) has accepted the filing of its Marketing Authorization Application for Cinryze for acute treatment and prophylaxis against hereditary angioedema, which was submitted through the centralized procedure in March 2010. ViroPharma is seeking European approval for both prevention and treatment of acute attacks of hereditary angioedema.

25 Mar 2010

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma Incorporated today announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy.

19 Mar 2010

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

ViroPharma Incorporated today announced the launch of 'Ryze Above' (www.ryzeabove.com), an exclusive patient resources program within the company's patient support program, CINRYZESolutions®. The Ryze Above program was created for HAE patients prescribed Cinryze, the first and only drug specifically approved to help prevent swelling and/or painful attacks in teenagers and adults with HAE.

19 Mar 2010

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

Data demonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology 2010 Annual Meeting in New Orleans.

3 Mar 2010

C1-INH replacement therapy effective for treating acute swelling attacks in HAE

C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Additional pharmacokinetic data presented at the meeting confirms that C1-INH concentrate has a longer half-life than other treatment options for HAE, which protects patients from rebound attacks.

2 Mar 2010

Angioedema News and Research

Further Reading

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Final data from Open-Label studies of Cinryze in patients with HAE now available

ACAAI, AGA Institute announce innovative initiative to raise awareness of HAE

TB Alliance, AstraZeneca sign research collaboration agreement to develop drugs against tuberculosis

New data on Cimzia for Crohn’s Disease treatment to be demonstrated at DDW 2010

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

FDA approves Novartis Pharmaceuticals' Zortress for preventing rejection of kidney transplants

CSL Behring calls for grant requests through LEAD program

Economic burden associated with HAE treatment: First-ever comprehensive examination

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

Dyax to use proceeds of public offering for commercialization and distribution activities of KALBITOR

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

C1-INH replacement therapy effective for treating acute swelling attacks in HAE

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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