Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

DRUG NEWS
(Updated May 7, 2019)

The FDA has approved the following drugs:
  • Ruzurgi (amifampridine) tablets to treat Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approved drug to treat pediatric patients with LEMS.
  • Vyndaqel (tafamidis meglumine) oral capsules and Vyndamax (tafamidis) oral capsules to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults and to decrease cardiovascular mortality and cardiovascular-related hospitalization.
The FDA has approved the following new indication:
  • Kadcyla (ado-trastuzumab emtansine) as an adjuvant treatment for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant therapy with a taxane and trastuzumab. Kadcyla is also approved to treat metastatic breast cancer. Labeling includes a warning regarding the risks of hepatotoxicity, cardiac toxicity, and embryo-fetal toxicity.
The FDA has approved the following expanded indications:
  • Benlysta (belimumab) intravenous injection to treat patients 5 years and older with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. Intravenous Benlysta was previously approved for adults only. Subcutaneous Benlysta is still approved for adults only.
  • Kalydeco (ivacaftor) oral tablets and granules to include treatment of cystic fibrosis (CF) in patients 6 months and older who have 1 mutation in the CF transmembrane conductance regulator gene that is responsive to ivacaftor based on clinical and/or in vitro assay data. Kalydeco was previously approved for patients 12 months and older.
  • Mavyret (glecaprevir/pibrentasvir) oral tablets to treat pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection who have not been treated, and for pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Both indications are approved in patients with no history of cirrhosis or with compensated cirrhosis (Child-Pugh A). Labeling includes a warning regarding the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV.

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