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Weekly Drug News Round-Up: February 8, 2017

Parsabiv Cleared for Secondary Hyperparathyroidism in Chronic Kidney Disease

Parsabiv is the only calcimimetic that can be given by the dialysis team 3 times a week after hemodialysis Read More...

Amgen’s Parsabiv (etelcalcetide) is the first new therapy for secondary hyperparathyroidism (HPT) in chronic kidney disease (CKD) in patients on hemodialysis in over a decade. Parsabiv’s mechanism of action is activation of the calcium-sensing receptor on the parathyroid gland to lower PTH levels. Approval was based on 2, 26-week Phase 3 studies with 1,023 patients with moderate-to-severe secondary HPT (PTH greater than 400 pg/mL) on hemodialysis. Significantly more Parsabiv patients met the primary endpoint of a greater than 30% reduction from baseline in PTH compared to placebo: 77 percent versus 11 percent in Study 1, and 79 percent versus 11 percent in Study 2, respectively.

FDA Approves Opdivo for Urothelial (Bladder) Cancer

Common side effects were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%) Read More...

The FDA has approved Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) for the treatment of patients with advanced or metastatic urothelial carcinoma (bladder cancer) whose cancer has progressed during or after treatment with platinum-containing chemotherapy. The recommended dose is 240 mg given as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity. In the CheckMate-275 Phase 2, open label study, investigators found 19.6% of patients responded to treatment by meeting the primary endpoint of objective response rate. A complete response was seen in 2.6% of patients, and 17% showed a partial response. The median duration of response was 10.3 months.

Xyzal Allergy 24HR Approved for Over-the-Counter Use

Xyzal is an oral antihistamine taken once daily

The FDA has approved Sanofi's Xyzal (levocetirizine) Allergy 24HR as an over-the-counter (OTC) treatment for the relief of symptoms associated with seasonal and year-round allergies. Xyzal offers relief from runny nose, sneezing, itchy watery eyes and itching of the nose or throat. Specifically, two formulations of OTC Xyzal are now approved for OTC use – 5 mg tablets for ages 6 years and older, as well as 0.5 mg/mL oral solution for ages 2 years and older. Common side effects include headache, muscle aches, and sleepiness or unusual drowsiness. Xyzal is expected to be commercially available in Spring 2017.

Chlorhexidine Gluconate Linked With Rare But Serious Allergic Reactions

Although rare, reports have increased over the last several years Read More...

Rare but serious allergic reactions with widely used skin antiseptic products containing chlorhexidine gluconate have been reported by the FDA. Chlorhexidine gluconate has a variety of uses: to clean the skin before surgery, as a prescription mouthwash to treat gingivitis, and as an oral chip to treat periodontal disease. Allergic reaction symptoms may include wheezing or difficulty breathing; swelling of the face; severe hives or rash; or shock, which is a life-threatening condition that occurs when the body is not getting enough blood flow. Patients should stop using the product and seek medical attention immediately or call 911 if they experience symptoms of a serious allergic reaction.

Rethinking Your Penicillin Allergy, Years Later

Some younger people who reported a reaction in the past might actually outgrow their allergy Read More...

If you’ve had what you think is an allergy to the antibiotic penicillin, experts are now recommending that you undergo confirmatory allergy testing. Penicillin-type drugs are safe and effective, and when people who aren’t really allergic avoid them, they may end up taking a much more toxic antibiotic or contributing to worldwide antibiotic resistance. In fact, researchers say 90 percent of people who have a penicillin allergy listed in their medical records don’t actually have a reaction when exposed during an allergy test. Doctors test for a penicillin allergy in a two-step process: first a skin test, and if negative, then patients are given a medically supervised oral challenge.