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 December 28, 2020)

The FDA has approved the following drugs:
  • Gemtesa (vibegron) oral tablets to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
  • Klisyri (tirbanibulin) topical ointment to treat actinic keratosis on the face or scalp.
  • Margenza (margetuximab-cmkb) intravenous injection, in combination with chemotherapy, to treat metastatic HER2-positive breast cancer in adult patients who have received 2 or more prior anti-HER2 regimens, at least 1 of which was for metastatic disease. Major risks include left ventricular dysfunction and embryo-fetal toxicity.
  • Orgovyx (relugolix) oral tablets to treat adult patients with advanced prostate cancer.
  • Riabni (rituximab-arrx) intravenous injection as a biosimilar to Rituxan (rituximab) to treat adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener granulomatosis), and microscopic polyangiitis. Major risks include fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B reactivation, and progressive multifocal leukoencephalopathy. 
The FDA has approved the following new indications:
  • Arcalyst (rilonacept) subcutaneous injection to maintain remission of deficiency of interleukin-1 receptor antagonist in adults and pediatric patients weighing at least 10 kg. Arcalyst is also indicated to treat cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome, and Muckle-Wells syndrome in adults and children 12 years and older.
  • Benlysta (belimumab) intravenous and subcutaneous injections to treat adults with active lupus nephritis who are receiving standard therapy. Benlysta is also approved to treat systemic lupus erythematosus. 
  • Kineret (anakinra) subcutaneous injection to treat deficiency of interleukin-1 receptor antagonist. Kineret is also approved to treat rheumatoid arthritis and neonatal-onset multisystem inflammatory disease.
  • Tagrisso (osimertinib) oral tablets as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. Tagrisso is also approved for first-line treatment of EGFR mutation-positive metastatic NSCLC and previously treated EGFR T790M mutation-positive metastatic NSCLC.
  • Xpovio (selinexor) oral tablets, in combination with bortezomib and dexamethasone, to treat adult patients with multiple myeloma who have received at least 1 prior therapy. Xpovio is also approved to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma and when administered with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody. 
The FDA has approved the following expanded indication:
  • Xeomin (incobotulinumtoxinA) intramuscular or intraglandular injection to treat chronic sialorrhea in pediatric patients 2 years and older, previously approved for the same indication in adults. Xeomin is also approved for cervical dystonia, blepharospasm, temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity, and to treat upper limb spasticity in adults, and upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. A major risk includes the distant spread of toxin effect.
 
The FDA has issued an Emergency Use Authorization (EUA) for the following:
  • Pfizer-BioNTech’s coronavirus disease 2019 (COVID-19) vaccine received EUA on December 11, 2020 for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 16 years and older. The EUA allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States.
  • Moderna’s COVID-19 vaccine received EUA on December 18, 2020 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 18 years and older. The EUA allows the Moderna COVID-19 vaccine to be distributed in the United States.
  

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