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Weekly Drug News Round-Up: June 28, 2017

Bevyxxa Approved for Longer-Term Prevention of Venous Thromboembolism

Portola expects to launch Bevyxxa between August and November 2017 Read More...

This past week the FDA approved Portola’s Bevyxxa (betrixaban), an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE). Bevyxxa in indicated for at-risk adult patients hospitalized for an acute medical illness, such as heart failure, stroke, infection and pulmonary disease and that results in moderate or severe restricted mobility and other risk factors for VTE. In the Phase 3 APEX study, Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo by 4.4 percent vs. 6.0 percent, respectively, with no significant increase in major bleeding.

FDA Clears Orphan Drug Haegarda for Hereditary Angioedema

People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract or airway Read More...

Haegarda (C1 esterase inhibitor [human]), from CSL Behring, has been given the FDA go-ahead to prevent hereditary angioedema (HAE) attacks in adolescent and adults. Haegarda is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy. Subcutaneous (under the skin) injections, with proper training, allows for at-home self-injection by the patient or caregiver. Compared to placebo over 16 weeks, Haegarda given twice per week at a dose of either 40 IU/kg or 60 IU/kg led to a significantly reduced number of HAE attacks. In studies, the most common side effects included injection site reactions, allergic reactions, nasopharyngitis (common cold symptoms) and dizziness.

Genentech’s New Rituxan Hycela May Mean Less Time in the Clinic

The product can now be delivered under the skin in minutes instead of hours through an IV infusion Read More...

The FDA has given the thumbs up to Genentech’s Rituxan Hycela (rituximab and hyaluronidase human), which includes the same monoclonal antibody as intravenous (IV) Rituxan (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin. Rituxan Hycela is given by subcutaneous (SQ) injection (under the skin) for adults with the following blood cancers: follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). Clinical studies showed Rituxan Hycela delivered similar blood levels and effectiveness of rituximab. The majority (77 percent) of patients preferred Rituxan Hycela over IV Rituxan due to less time spent in the clinic.

Common Heartburn Drugs and Alzheimer’s Disease: Is There a Link?

These drugs are also available over-the-counter (OTC) without a prescription Read More...

Proton Pump Inhibitors (PPIs) such as Prevacid, Prilosec and Nexium, are used to treat digestive problems like acid reflux. Recent studies have brought on concerns that PPI use might be linked to an elevated risk of dementia and Alzheimer's disease in those over 75 years of age. Researchers looked at data from over 10,000 Americans, aged 50 or older, with normal brain function or mild thinking difficulties. Researchers found those who used PPIs were at a lower risk of a decline in thinking skills, but also were also more likely to use anticholinergic medicines like Benadryl (diphenhydramine), often found in OTC sleep medications, that have been linked to thinking difficulties.

Would You Prefer Your Flu Vaccine in a Patch Over a Shot? Study

The patch triggered a strong immune response and did not cause any serious side effects Read More...

Getting a yearly flu shot is not the task we look forward to the most; in fact, only 40% of people get their flu vaccine each year. But new forms of the influenza vaccine may be on the way. Early research published in The Lancet shows that an experimental flu vaccine patch with dissolving microneedles appears safe and effective. The bandage-sized strip has 100 solid, water-soluble and painless microneedles. Even more enticing is that the patch could be sent by mail, applied at home and does not need refrigeration. This technology could result in a method to deliver other vaccines, too. The new patch research comes from Georgia Institute of Technology and Emory University, both in Atlanta.