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Weekly Drug News Round-Up: June 1, 2016

Once-Daily Jentadueto XR Wins Approval for Type 2 Diabetes

Close to 29 million people in the US have type 2 diabetes Read More...

Type 2 diabetes patients often need to take multiple medications daily. Extended-release, once daily agents can ease this burden. This week the US Food and Drug Administration (FDA) approved Boehringer Ingelheim-Eli Lilly's Jentadueto XR. Jentadueto XR contains 2.5 mg or 5 mg of linagliptin (Tradjenta) with 1000 mg of metformin XR. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that stimulates the pancreas to produce more insulin and the liver to produce less glucose. Metformin lowers glucose production by the liver and its absorption in the intestine. As with other metformin products, the Jentadueto XR label contains a boxed warning for the risk of lactic acidosis.

Invokamet Now Approved for First-Line Treatment of Type 2 Diabetes

Invokamet was first approved in August of 2014

Invokamet (canagliflozin and metformin), an oral medication for type 2 diabetes, may now be prescribed first-line in adults who are not already being treated with canagliflozin or metformin and may also benefit from dual therapy. Previously, Invokamet was labeled to be prescribed only in patients who were already being treated with both medications separately. Invokamet is a sodium glucose co–transporter 2 (SGLT2) inhibitor (canagliflozin) and biguanide (metformin) antidiabetic combination. The new Invokamet indication aligns with recent type 2 diabetes treatment guidelines, which recommend dual therapy for patients with higher A1C levels. Kidney function should be evaluated using estimated glomerular filtration rate (eGFR) prior to initiating therapy with Invokamet.

FDA Approves Zinbryta for Multiple Sclerosis

A boxed warning alerts prescribers that Zinbryta can cause severe liver injury Read More...

Multiple sclerosis, a chronic, inflammatory, autoimmune disease of the central nervous system, has been reported as the leading cause of disability in young adults 20 to 40 years of age. The FDA has now approved AbbVie and Biogen’s Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta, a humanized monoclonal antibody, is a long-acting injection that is self- administered by the patient monthly. In studies, patients using Zinbryta had fewer clinical relapses than patients taking placebo or Avonex (interferon beta-1a).

Ocaliva Clears FDA for Primary Biliary Cholangitis

Ocaliva will be distributed through a specialty pharmacy network Read More...

Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that occurs primarily in women over the age of 40. In response, the FDA has granted accelerated approval for Intercept’s Ocaliva (obeticholic acid), a first-in-class farnesoid X receptor (FXR) agonist for the treatment of primary biliary cholangitis (biliary cirrhosis). Ocaliva is combined with ursodeoxycholic acid (UDCA) in adults with an inadequate UDCA response or as monotherapy in adults unable to tolerate UDCA. In Phase 3 trials, Ocaliva met the primary endpoint in 46% of patients. Ocaliva is expected to be available by mid-June or sooner.

Probuphine Implant Approved for Treatment of Opioid Dependence

It’s shocking: forty-five people in the US die every day from a prescription opioid overdose Read More...

As an added weapon in the treatment of opiate addiction, the FDA has approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine consists of four, one-inch-long rods that are implanted under the skin and provide a constant, low-level dose of buprenorphine for six months. In studies, 63 percent of Probuphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment – similar to the 64 percent of those who responded to sublingual (under the tongue) buprenorphine alone.