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Monthly News Roundup - May 2018

Aimovig Cleared as First-In-Class for Migraine Prevention

Migraines are painful, debilitating headaches that can negatively affect a patient’s work and quality-of-life. This month the U.S. Food and Drug Administration (FDA) approved Amgen’s Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is the first FDA-approved preventive migraine treatment known as a calcitonin gene-related peptide (CGRP) receptor antagonist. These agents work by blocking the activity of calcitonin gene-related peptide involved in migraine attacks. In three studies of patients with episodic migraine, Aimovig-treated patients experienced 1 to 2.5 fewer monthly migraine days, on average, compared to placebo. Common side effects included injection site reactions and constipation.

Lucemyra: First Non-Opioid To Manage Opioid Withdrawal Symptoms

The FDA has approved Lucemyra (lofexidine hydrochloride), from US WorldMeds, to reduce the severity of withdrawal symptoms and allow a more abrupt discontinuation of opioids in adults. Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine thought to contribute to opiate withdrawal symptoms. It is not a treatment for opioid use disorder (OUD), but is used to help manage OUD. While Lucemyra may lessen the severity of withdrawal symptoms, such as anxiety, nausea, stomach cramps, and sleep problems, it may not completely prevent them and is only approved for treatment for up to 14 days.

Hospira’s Retacrit OK’d as First Epoetin Alfa Biosimilar for Anemia

This May the FDA approved Hospira's Retacrit (epoetin alfa-epbx), a biosimilar to Epogen/Procrit (epoetin alfa), for treatment of anemia caused by chronic kidney disease, chemotherapy, use of zidovudine in patients with HIV, and for reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Retacrit, an erythropoiesis-stimulating agent (ESA), was approved based on data showing that it is highly similar to Epogen/Procrit and has no clinically meaningful differences in terms of safety, purity and potency. As with other ESAs, a boxed warning informs of the risk of death, heart attack, stroke, blood clots and cancer progression or recurrence.

Andexxa FDA-Approved as First Factor Xa Inhibitor Antidote

The FDA has given the go-ahead this month to Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) from Portola Pharmaceuticals, a recombinant modified human Factor Xa (FXa) protein. Andexxa is the first drug approved for reversal of anticoagulation for serious bleeding in patients treated with the Factor Xa inhibitors rivaroxaban (Xarelto) or apixaban (Eliquis). Andexxa works by acting like a "trap”, binding to the Factor Xa inhibitor to reverse the anticoagulant effect. In Phase III studies, Andexxa rapidly and significantly reversed anti-Factor Xa activity. The median decrease in anti-Factor Xa activity from baseline was 97% for rivaroxaban (Xarelto) and 92% for apixaban (Eliquis).

Sun Pharma’s Yonsa Approved to Treat Advanced Prostate Cancer

Among several May approvals, the FDA okayed Yonsa (abiraterone acetate) in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Yonsa is a unique, ultramicrosize (smaller particle size) formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga). The CYP17 enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis. Patients receiving Yonsa should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy (surgical removal of both testicles). Yonsa tablets may have different dosing and food effects compared to other abiraterone acetate products.

Posted: May 2018