Daxxify Approved for Cosmetic Use
The U.S. Food and Drug Administration (FDA) approved a new botulinum toxin product on Sept. 7, 2022. Daxxify™ (daxibotulinumtoxinA-lanm) is a neuromuscular blocker that is indicated for the reduction of moderate-to-severe glabellar (frown) lines in adult patients. Currently, Daxxify is not approved for treating any other condition and it is not interchangeable with any other botulinum product. It will be administered by specifically trained healthcare providers as five equal intramuscular (IM) injections totaling 40mg into the muscles between the eyebrows. Treatments should be separated by at least 90 days. For some patients in the clinical trials, treatment effects were visible in as little as one day and effects lasted up to nine months for some. Daxxify uses a patented technology that prolongs its effects, resulting in an average duration of glabellar smoothing of about six months, significantly longer than the effects produced by presently available botulinum products. Additionally, Daxxify does not contain any human albumin or animal ingredients. Small percentages of study patients experienced headaches, droopy eyelids, and/or weakness in their facial muscles after treatments. The manufacturer, Revance Therapeutics, has begun training specialists for a limited launch in Nashville, TN, with a wider release directly to cosmetic clinics, plastic surgeons, and other qualified providers planned for later. The cost has not been announced. All botulinum toxin products have Medication Guides and boxed warnings that they potentially may cause widespread side effects, such as muscle weakness and vision changes if they migrate away from the areas where they are injected. Rarely, do serious breathing or swallowing problems can occur. Side effects may not be evident until several months after the product has been injected. Here is prescribing information.
FDA Approves Stimufend
Stimufend® (pegfilgrastim-fpgk – Fresenius Kabi), the sixth biosimilar for Neulasta® (pegfilgrastim – Amgen), was FDA approved on Sept. 1, 2022. It is the company’s first biosimilar approval in the U.S. Stimufend is indicated to decrease the risk of infections for patients who are receiving cancer drugs that interfere with the bone marrow’s production of blood cells and that are associated with a clinically significant incidence of febrile neutropenia, a side effect of some chemotherapy (chemo). Although multiple variables are involved in having febrile neutropenia, approximately 60,000 American patients develop it annually during treatment, with patients who have blood cancers most likely to be affected. Pegfilgrastim is a PEGylated form of the granulocyte colony-stimulating factor (G-CSF) analog, filgrastim, which causes cells in the bone marrow to produce more neutrophils. PEGylation gives it a longer duration of action. The recommended adult dose of Stimufend is 6mg (one prefilled syringe) as a subcutaneous (SC) injection at least two weeks before or one day after the first chemo treatment in each cycle. Doses for children who weigh less than 45kg (about 100 pounds) are based on body weight and given on the same schedule as adult dosing. The launch is planned for early 2023, but no cost estimates are available. Along with the branded product, other biosimilars already available are Fulphila® (pegfilgrastim-jmdb – Mylan), Nyvepria™ (pegfilgrastim-apgf – Pfizer), Udenyca® (pegfilgrastim-cbqv – Coherus BioSciences) and Ziextenzo® (pegfilgrastim-bmez – Sandoz) — Another biosimilar, Fylnetra™ (pegfilgrastim-pbbk – Amneal Pharmaceuticals), was FDA approved in May 2022, but it is not yet sold in the U.S.
New Indication for Imfinzi
In combination with chemo that includes gemcitabine and cisplatin, AstraZeneca’s programmed death ligand 1 (PD-L1) inhibitor, Imfinzi® (durvalumab) was approved on Sept. 2, 2022, to treat adults who have advanced cancers of the biliary tract (gallbladder and bile ducts). About 85% of the roughly 8,000 U.S. patients diagnosed annually with biliary cancers die within five years. Also, FDA approved to treat of some extensive-stage small cell lung cancers (ES-SCLC) and some non-small cell lung cancers (NSCLC), Imfinzi is administered as one-hour intravenous (IV) infusions. To treat biliary tract cancers, it is used once per 21-day cycle before the chemo drugs are given. For patients weighing less than 30kg (66 pounds), doses are 20mg/kg. Heavier patients receive 1,500mg/dose. While the patient also receives chemo, Imfinzi is given for eight cycles or less. When chemo is finished, treatment with Imfinzi switches to once every four weeks and continues until its side effects are intolerable or cancer returns. For its revised prescribing information, go here.
Orkambi’s Pediatric Indication Extended
On Sept. 2, 2022, Orkambi® (lumacaftor/ivacaftor – Vertex) was FDA approved for use in children who are as young as 12 months old and who have cystic fibrosis (CF) that tests positive for two copies of a specific deletion (F508del) in the CF transmembrane conductance regulator (CFTR) gene. The drug works in two ways. Lumacaftor is a CFTR corrector, which helps CFTR proteins reach the cell surface. Ivacaftor is a CFTR potentiator, which helps keep the CFTR protein channels on the cell surfaces open longer to increase the flow of salt and water into and out of the cells. In addition to oral tablets, Orkambi is available as granules that can be mixed with one teaspoonful of a liquid or soft food and given along with food that contains a high amount of fat. For children up to the age of five years old, both the child’s age and weight are considered for determining dose levels. Doses are given as close as possible to 12 hours apart. Here is the current prescribing information.