Portola's anticoagulant drug BevyxXa wins FDA approval | FDA grants approval to CSL Behring's hereditary angioedema drug | Cara's uremic pruritus drug wins FDA breakthrough status
June 26, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Portola's anticoagulant drug BevyxXa wins FDA approval
The FDA has approved Portola Pharmaceuticals' drug BevyxXa, or betrixaban, the first oral medication developed to inhibit blood coagulation in patients who are hospitalized for long periods, such as those with pulmonary disease and heart failure or who have suffered a stroke.
Reuters (6/23),  Xconomy (6/23) 
FDA grants approval to CSL Behring's hereditary angioedema drug
CSL Behring's Haegarda, or human C1 esterase inhibitor, subcutaneous injection has been approved by the FDA to prevent hereditary angioedema attacks in adolescents and adults. Patients treated with Haegarda demonstrated significantly fewer HAE attacks compared with placebo use.
eMPR (6/23) 
Cara's uremic pruritus drug wins FDA breakthrough status
Cara Therapeutics' I.V. CR845, a treatment for moderate to severe uremic pruritus in patients with chronic kidney disease who undergo hemodialysis, has been granted breakthrough therapy designation by the FDA. A Phase II/III study of I.V. CR845 in patients with uremic pruritus showed a 68% reduction in worst itching scores and 100% improvement in quality of life domains compared with placebo.
Seeking Alpha (free registration) (6/23) 
FDA gives orphan status to Idera's advanced melanoma drug
The FDA has given orphan drug designation to Idera Pharmaceuticals' IMO-2125 as a treatment for patients with stages IIB to IV melanoma. The company has an ongoing midstage study of the drug.
Seeking Alpha (free registration) (6/23) 
Draft executive order seeks easing of pharma R&D rules
A draft executive order instructs agencies to review policies that could raise the cost of pharmaceutical research and development and to recommend policy changes in fiscal 2019 budget proposals. The draft instructs trade negotiators to seek deals that increase the prices other countries pay for American prescription drugs.
Roll Call (free content) (6/23) 
Global Focus
UK regulators accept Santhera's Raxone for early-access scheme
UK regulators accepts Santhera's Raxone for early-access scheme
(Jeff J Mitchell/Getty Images)
Santhera Pharmaceuticals' Raxone, or idebenone, has been accepted by the UK's Medicines and Healthcare products Regulatory Agency to its Early Access to Medicines Scheme as a treatment for patients with Duchenne muscular dystrophy.
BioCentury (6/22) 
EMA panel backs Aveo's renal cell carcinoma drug
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended for approval Aveo Pharmaceuticals' Fotivda, or tivozanib, as a treatment for patients with advanced renal cell carcinoma and whose disease is VEGF receptor and mammalian target of rapamycin pathway inhibitor-naive following disease progression after a prior treatment with cytokine therapy. The decision was based on a late-stage study in which Fotiva achieved the primary endpoint of improving progression-free survival in patients compared with sorafenib use.
BioCentury (6/23) 
Food & Dietary Supplements
Bone fragments spur recall of toddler foods, chicken bites
More than 27 tons of organic frozen chicken products have been recalled by Overhill Farms because consumers found bone fragments in the products. The recalled items include Yummy Spoonfuls brand toddler meals in the chicken carrot bites, chicken sweet potato bites and chicken broccoli bites varieties, as well as three varieties of Overall Farms-branded 30-pound bulk cases, which were shipped to retail locations nationwide.
Food Safety News (6/25) 
Medical Devices
C.R. Bard's covered iliac stent gets premarket approval from FDA
The FDA has given C.R. Bard premarket approval for its LifeStream covered iliac stent, a device intended for treating patients with peripheral artery disease. The approval is for the use of the device in treating atherosclerotic lesions in external and common iliac arteries with lesion lengths of up to 100 mm and diameters ranging from 4.5 mm to 12 mm.
MassDevice (Boston) (6/23) 
FDA labels recall of Teleflex unit's catheters as Class I
A recall initiated by Teleflex covering 4,679 units of Venture surgical catheters, manufactured by its subsidiary Vascular Solutions, has been classified by the FDA as Class I. The recall was issued because of a risk of embolism, which could happen if an excess material within the catheter separates during use and enters the body.
Star Tribune (Minneapolis-St. Paul, Minn.) (tiered subscription model) (6/23) 
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