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.

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.

28 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.

21 Jun 2010

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Dyax Corp. and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA, announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.

21 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

11 Jun 2010

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Celgene International Sàrl today announced that researchers presented data from an investigator-initiated Phase II study of lenalidomide (REVLIMID) in untreated patients with chronic lymphocytic leukemia at the annual meeting of the American Society of Clinical Oncology.

8 Jun 2010

EDEMA4 study results of KALBITOR for treatment of acute attacks of HAE published

Dyax Corp. announced today the publication of results from its second Phase 3, placebo-controlled trial, known as EDEMA4, evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema. The results, published in the June 2010 issue of the Annals of Allergy, Asthma, and Immunology, indicate that KALBITOR is effective in ameliorating HAE attacks, resolving associated symptoms and preventing attack progression.

7 Jun 2010

Celgene reports initial data from investigator-initiated study of REVLIMID

Celgene International Sàrl today announced that initial data from an investigator-initiated study of REVLIMID (lenalidomide) plus Rituxan (rituximab) in patients with newly diagnosed indolent B-cell non-Hodgkin's lymphoma (NHL) were presented at the annual meeting of the American Society of Clinical Oncology.

5 Jun 2010

Researchers present clinical outcomes of lenalidomide in patients with large B-cell lymphoma

Celgene International Sàrl today announced researchers at the annual meeting of the American Society of Clinical Oncology presented data from an evaluation of lenalidomide (REVLIMID) in patients with diffuse large B-cell lymphoma either with a germinal center B-cell or non-germinal center B-cell phenotype.

5 Jun 2010

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