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Weekly Drug News Round-Up: December 13, 2017

Sanofi’s Admelog Cleared As Fast-Acting Insulin Rival for Humalog

Admelog is used within 15 minutes before a meal or immediately after Read More...

This week, the FDA approved Sanofi's Admelog (insulin lispro injection), a rapid-acting human insulin analog used to improve blood sugar control in adult and pediatric patients aged 3 years and older with type 1 diabetes, and adults with type 2 diabetes. Admelog is the first fast-acting insulin approved as a “follow-on” product that relied, in part, on the FDA’s finding of safety and effectiveness for Lilly’s Humalog (insulin lispro injection) to support approval. The Admelog-specific data did include two phase 3 clinical trials which enrolled approximately 500 patients in each. Admelog is expected to launch in early 2018 and will be available in a vial and SoloStar pen.

Sinuva Sinus Implant, a New In-Office Treatment for Recurrent Nasal Polyps

Nasal polyps are growths in the nasal passages that can cause congestion, infections and loss of smell Read More...

Sinuva (mometasone furoate) is Intersect ENT’s corticosteroid-eluting sinus implant now approved for the treatment of recurrent nasal polyps in patients who have had previous ethmoid sinus surgery. In clinical studies of 400 patients, including the landmark RESOLVE II pivotal study, the primary efficacy endpoints were met with statistical significance. These included a reduction from baseline in bilateral polyp grade (p=0.007) and a reduction from baseline Nasal Obstruction/Congestion score (p=0.007). Significant improvements in sense of smell, nasal congestion and percent ethmoid sinus obstruction were also demonstrated. Mometasone is also found in the commonly used allergy nasal spray Nasonex. Sinuva is expected to launch in the second-quarter of 2018.

Sunovion’s Lonhala Magnair Cleared as Nebulized Option for COPD

Lonhala Magnair is expected to be available in pharmacies in early 2018 Read More...

Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for the long-term, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sunovion’s Lonhala Magnair was FDA-approved as the first nebulized, LAMA treatment option for COPD. The technology is based on use of the Magnair, a quiet, closed system nebulizer that is designed to deliver the drug in 2 to 3 minutes and allows people to breathe normally while using the device. In Phase 3 placebo-controlled studies in moderate-to-severe COPD, Lonhala Magnair demonstrated statistically significant changes from baseline in trough forced expiratory volume in one second (FEV1) at Week 12.

Nucala is First Drug OK’d for Rare Eosinophilic Granulomatosis With Polyangiitis

The FDA application was granted Priority Review and Orphan Drug designations Read More...

Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body; it can affect multiple organs. This week the FDA approved the first treatment for EGPA, the drug Nucala (mepolizumab), an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) also approved for patients with severe eosinophilic asthma. In a 52-week trial that compared Nucala 300 mg subcutaneous injection every 4 weeks to placebo, patients achieved a significantly greater accrued time in remission (symptom free) compared with placebo. Common side effects included headache, injection site reaction, back pain, and fatigue.

Amgen's Repatha Now Labeled to Prevent Heart Attack and Stroke

The FDA also approved Repatha for primary hyperlipidemia to reduce LDL cholesterol Read More...

Repatha (evolocumab) is a novel drug that can dramatically reduce low density lipoprotein (LDL) cholesterol in patients already on maximally-tolerated statin therapy who need further LDL lowering. But what about clinical outcomes? Repatha is now approved as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. In the Repatha cardiovascular outcomes study (FOURIER), Repatha reduced the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularization by 22%. Repatha was first approved in 2015 for patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease in need of additional LDL lowering. Review this Drugs.com PCSK9 Inhibitor slideshow to learn more.

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