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Monthly News Roundup - August 2018

Xerava Granted Approval for Complicated Intra-Abdominal Infections

The U.S Food and Drug Administration (FDA) has approved Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years and older. Xerava, from Tetraphase Pharmaceuticals, is a fluorocycline antibiotic in the tetracycline class with potent activity against multi-drug resistant pathogens. In pivotal phase 3 studies, twice-daily intravenous eravacycline met the primary endpoint and was shown to be statistically non-inferior (not worse than) treatment with ertapenem (Invanz) and meropenem (Merrem), both carbapenem antibiotics. In trials, Xerava achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. Common side effects with Xerava include infusion site reactions, nausea, and vomiting.

Shire’s Takhzyro Now OK'd for Rare Hereditary Angioedema (HAE)

Hereditary angioedema (HAE) is a rare genetic condition that causes severe swelling in the body, including the stomach, limbs, face and throat. It typically begins in childhood and worsens following puberty. The FDA has cleared Shire’s Takhzyro (lanadelumab-flyo) to treat patients 12 years and older with types I and II HAE. Takhzyro, a plasma kallikrein inhibitor, is the first monoclonal antibody approved in the U.S. to treat this condition. In studies, Takhzyro led to significant reductions in HAE attacks compared to placebo over a 6-month treatment period. Side effects may include injection site reactions, upper respiratory infections, rash, and headache, among others.

FDA Clears Onpattro: First Drug for Polyneuropathy Due to hATTR

The FDA has approved Onpattro (patisiran) for patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This form of polyneuropathy is a rare, debilitating and often fatal genetic disease with a buildup of abnormal amyloid protein in the nerves, heart and other organs. Onpattro, from Alnylam Pharmaceuticals, is the first FDA approval in a new class called small interfering ribonucleic acid (siRNA) drugs. Onpattro works by encasing siRNA in lipids and stops the production of the amyloid proteins. In studies, patients receiving Onpattro infusion had better scores on measures of polyneuropathy, walking assessment, nutritional status and activities of daily living compared to placebo. Common side effects are flushing, back pain, nausea, abdominal pain, difficulty breathing, and headache.

Jornay PM for Evening Dosing in ADHD Soon Available

Control over their child’s Attention Deficit Hyperactivity Disorder (ADHD) symptoms during the early morning routine remains a significant concern for parents. Jornay PM is a new extended-release capsule formulation of methylphenidate, taken once-daily in the evening for the treatment of ADHD in patients 6 years and older. Jornay PM utilizes a unique methylphenidate delivery technology (Delexis platform) that delays initial release of the drug for up to 10 hours and then controls release throughout the day. In Phase 3 studies, ADHD symptoms improved during the early morning, before school activities, and throughout the daytime. Jornay PM is expected to be available in the first half of 2019.

Lenvima FDA-Approved for First-line Treatment in Liver Cancer

The FDA has cleared Eisai and Merck’s kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be fully removed with surgery. Approval is based on the first-ever positive Phase 3 study against an active comparator in unresectable hepatocellular carcinoma. In the REFLECT Phase 3 study, Lenvima was shown to be noninferior to (not worse than) sorafenib (Nexavar) with a median overall survival of 13.6 months versus 12.3 months with sorafenib. Serious adverse reactions included hepatic (liver) encephalopathy (5%), hepatic failure (3%), ascites (3%) and decreased appetite (2%).

Merck’s New HIV Drugs Delstrigo and Pifeltro FDA-Approved

To close out the month, the FDA approved two doravirine-based HIV-1 medicines from Merck: Pifeltro (doravirine, 100 mg) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other antiretroviral medicines, and Delstrigo contains doravirine, plus lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) in a single tablet regimen. Both drugs are used for HIV-1 infection in adults with no prior antiretroviral treatment and are given once daily. Efficacy was shown in the Phase 3 Drive-Ahead (Delstrigo) and Drive-Forward (Pifeltro) trials, which demonstrated comparable (non-inferior) viral suppression rates through 48 weeks versus active comparators. Side effects in the Pifeltro study group included nausea (7%), headache (6%), fatigue (6%), diarrhea (5%) and abdominal pain (5%).

Posted: August 2018


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