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Weekly Drug News Round-Up: January 3, 2018

FDA Approves Steglatro for Type 2 Diabetes

The SGLT2 inhibitors block the kidney from reabsorbing sugar (glucose) which is eliminated in the urine and lowers blood sugar Read More...

The U.S. Food and Drug Administration (FDA) has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor used with diet and exercise to improve blood sugar control in adults with type 2 diabetes. In seven Phase 3 studies of 4,800 patients, Steglatro was studied alone or in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea. Significant A1C reductions and weight loss were noted when used alone or in combination with sitagliptin. The FDA has also approved two combo agents that contain ertugliflozin: Segluromet (ertugliflozin and metformin hydrochloride) with the biguanide metformin, and Steglujan (ertugliflozin and sitagliptin), with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin.

Bausch + Lomb’s OTC Lumify is Approved for Eye Redness

Ocular redness is a common condition that can be caused by inflammation of almost any part of the eye Read More...

In December, the FDA approved Bausch + Lomb’s Lumify (brimonidine tartrate ophthalmic solution 0.025%) as the first over-the-counter (OTC) eye drop that contains low-dose brimonidine tartrate for the treatment of ocular redness (red eyes). Brimonidine (Alphagan P), first approved by the FDA for intraocular pressure (IOP) reduction in glaucoma patients, is available at higher doses in prescription eye care products. Lumify, an alpha-adrenergic agonist, selectively constricts veins in the eye, increasing the availability of oxygen and reducing the potential risk of rebound redness. Lumify should be commercially available in the second quarter of 2018.

Macrilen Cleared for Diagnosis of Adult Growth Hormone Deficiency

Roughly 60,000 tests for suspected AGHD are being conducted each year across the United States, Canada and Europe Read More...

Macrilen (macimorelin), from Aeterna Zentaris, is a growth hormone secretagogue receptor agonist now approved for the diagnosis of adult growth hormone deficiency (AGHD). Macrilen is an orally available ghrelin agonist that stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Stimulated growth hormone levels are measured in four blood samples over 90 minutes after oral administration of Macrilen for the assessment of growth hormone deficiency. Prior to Macrilen, the gold standard for evaluation of AGHD was the insulin tolerance test, an inconvenient test requiring many blood draws over several hours that also requires hypoglycemia.

Tasigna Label Update: Certain CML Patients Can Stop Treatment

Tasigna is a kinase inhibitor that blocks a protein called BCR-ABL, which promotes abnormal cell growth Read More...

The FDA has updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). CML is a blood cancer of the bone marrow. The new labeling states that patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a approved test, may be eligible to stop taking Tasigna.

New Drug Approvals in 2017: Advancing Innovation

A look back at some of the top advances in drug therapy for 2017 Read More...

Novel drug approvals in 2017 were frequent and clinically impactful. Important research discoveries spanned from CAR-T cell therapy to treat advanced blood cancers, to a directly delivered ocular gene therapy with Luxturna that can help treat a sight-stealing disease. Rare diseases without previous therapy, new agents to fight bacterial resistance, and innovative vaccines for vulnerable populations such as children and the elderly also passed through FDA review. Type 2 diabetes, hepatitis C virus, and HIV were other public health illnesses that gained added approvals. Here, review some of the top new and unique drug approvals of 2017 with