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Monthly News Roundup - May 2016

FDA Approves Zinbryta for Multiple Sclerosis

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 US Food and Drug Administration (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). A boxed warning alerts prescribers that Zinbryta can cause severe liver injury.

Ocaliva Clears FDA for Primary Biliary Cholangitis

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 within 10 days and will be distributed through a specialty pharmacy network.

Probuphine Implant Approved for Treatment of Opioid Dependence

The statistics are shocking: forty-five people in the US die every day from a prescription opioid overdose. 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.

Genentech’s First-in-Class Tecentriq Wins Approval to Target Bladder Cancer

The FDA has approved Genentech’s Tecentriq (atezolizumab) to treat urothelial carcinoma, a common bladder cancer. Tecentriq is the first FDA-approved PD-L1 inhibitor and the latest in the broader class of PD-1/PD-L1 targeted biologics approved by the FDA in the last two years. Tecentriq, now the fourth approved immune checkpoint inhibitor, boosts the body’s own immune system to destroy cancer cells. In studies, 14.8% of patients had at least partial shrinkage of tumors lasting 2.1 to over 13.8 months at the time of analysis. Approved anti-PD-1 drugs include Merck's Keytruda (pembrolizumab) and BMS's Opdivo (nivolumab).

Nuplazid is First Drug Available for Parkinson’s Disease Psychosis

The FDA has approved Acadia’s once-daily Nuplazid (pimavanserin) tablets, the first atypical antipsychotic to treat hallucinations and delusions associated with Parkinson’s disease-linked psychosis (PDP). Nuplazid exhibits inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors. In a six-week study of 199 patients, Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease. Nuplazid shows no measurable activity at dopaminergic receptors, but common side effects may include swelling (peripheral edema), nausea, and confusion.

Posted: May 2016