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Weekly Drug News Round Up - September 2, 2015

Varubi Approved to Treat Nausea and Vomiting Due to Cancer Treatment

Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist

Nausea and vomiting is a difficult and sometimes prolonged side effect experienced by cancer patients undergoing chemotherapy. In response, the U.S. Food and Drug Administration (FDA) has approved Varubi (rolapitant) tablets to prevent delayed phase chemotherapy-induced nausea and vomiting (CINV). Varubi can be used in combination with other agents, such as granisetron and dexamethasone, to help control CINV. In clinical trials, common side effects with Varubi included a low white blood cell count (neutropenia), hiccups, decreased appetite and dizziness. Varubi also inhibits the CYP2D6 enzyme and should not be used with the antipsychotic thioridazine due to the possibility of an abnormal heart rhythm.

Repatha: Second PCSK9 Inhibitor to Hit U.S. Market

New cholesterol agent targets hard-to-treat patients

The U.S. Food and Drug Administration has approved Amgen's Repatha (evolocumab). Repatha injection is indicated for use in addition to diet and statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease (ASCVD), such as heart attacks or strokes, who require additional lowering of LDL cholesterol. In 12- and 52-week Phase 3 trials Repatha lowered LDL-C by roughly 60% across all study groups; in HoFH, evolocumab reduced LDL-C by 31%. Common side effects include nasopharyngitis (common cold), upper respiratory tract infections, and injection site reactions. Praluent was the first approved PCSK9 inhibitor.

Synjardy Gets FDA Green Light For Type 2 Diabetes

Like any drug containing metformin, the risk of lactic acidosis is a rare possibility Read More...

The U.S. Food and Drug Administration has approved Synjardy (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim and Eli Lilly, for the treatment of adults with type 2 diabetes. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a biguanide, lowers liver glucose production and absorption by the intestine. Synjardy is the third product containing empagliflozin available in the U.S., alongside Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin).

Sunovion’s Aptiom Gains New Indication for Partial-Onset Seizures

Roughly 3 million people in the U.S. have some form of epilepsy Read More...

Aptiom (eslicarbazepine acetate) was first approved in 2013 as adjunctive (add-on) therapy for partial-onset seizures. The U.S. Food and Drug Administration (FDA) has now approved Aptiom as monotherapy for the treatment of partial-onset seizures, which means it can be used alone in patients who just start therapy, or who convert from other seizure drugs to Aptiom. Aptiom tablets are given once-daily. In the Aptiom monotherapy trials, the most common treatment-related side effects included headache, dizziness, fatigue, somnolence, and nausea.

FDA: Type 2 Diabetes Drug Class May Cause Severe Joint Pain

FDA is updating product labeling for the entire drug class Read More...

The U.S. Food and Drug Administration (FDA) is warning that type 2 diabetes medicines from the drug class dipeptidyl peptidase-4 (DPP-4) inhibitors may lead to severe joint pain. This class includes the individual and various combination drugs with sitagliptin (Januvia, Janumet, Janumet XR), saxagliptin (Onglyza, Kombiglyze XR), linagliptin (Glyxambi, Tradjenta, Jentadueto), and alogliptin (Nesina, Kazano, Oseni). The FDA recommends that patients do not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. Clinicians should discontinue DPP-4 inhibitors in their patients if they suspect this class is causing the severe joint pain.