Iyuzeh Approved for Treating Eye Conditions
Iyuzeh™ (latanoprost ophthalmic solution) 0.005%, was approved by U.S. Food and Drug Administration (FDA) on Dec. 13, 2022. A preservative-free prostaglandin analogue that reduces elevated intraocular pressure (IOP), it is indicated for treating open-angle glaucoma and ocular hypertension. One drop is used in each affected eye once a day in the evening. As with all ophthalmic prostaglandins, using Iyuzeh may permanently darken the colors of the eyes and eyelids. Eyelash properties, including color, length, and thickness, also may be increased. The manufacturer, Thea Pharma, expects to launch Iyuzeh in the U.S. during the second half of 2023. Latanoprost 0.005% eye products already on the U.S. market include Xalatan® ophthalmic solution (Pfizer), Xelpros™ ophthalmic emulsion (Sun Pharma), and generics for the solution formulation. Additionally, several other prostaglandins also are available to treat intraocular pressure. Here is prescribing information for Iyuzeh.
Additional Biosimilar for Humira Approved
Fresenius Kabi received approval from the FDA on Dec. 13, 2022, for Idacio® (adalimumab-aacf) injection. A biosimilar to the citrate-free version of AbbVie’s Humira (adalimumab), it is a monoclonal antibody that inhibits tumor necrosis factor (TNF), to reduce inflammation. Its indications are the same as Humira’s — for treating adults who have ankylosing spondylitis (AS), plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA), or ulcerative colitis (UC), and for treating children at least two years of age who have polyarticular juvenile idiopathic arthritis (JIA) and patients aged six years and older for Crohn’s disease. It is given by subcutaneous (SC) injections — usually once every two weeks — through prefilled syringes and auto-injectors. For many of its adult indications, the recommended maintenance doses are 40mg, after higher loading doses. Pediatric dosing is based on the child’s weight. A boxed warning on the labels of all TNF blockers and information in Medication Guides for patients outlines the increased risks of cancer and serious infections that may be associated with their use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. The provisions of a settlement agreement will allow Idacio to be released in July 2023. It is not interchangeable with Humira or any other Humira biosimilar including Abrilada™ (adalimumab-afzb – Pfizer), Amjevita™ (adalimumab-atto – Amgen), Cyltezo® (adalimumab-adbm – Boehringer Ingelheim), Hadlima (adalimumab-bwwd, Samsung Bioepis/Organon), Hulio® (adalimumab-fkjp – Mylan/Fujifilm Kyowa Kirin Biologics), Hyrimoz™ (adalimumab-adaz – Sandoz) or Yusimry™ (adalimumab-aqvh – Coherus BioSciences). Prescribing information for Idacio is here.
New Tecentriq Indication
Under Priority Review and with Breakthrough Therapy and Orphan Drug designations, Genentech’s programmed death receptor-ligand 1 (PD-L1) inhibitor, Tecentriq® (atezolizumab) injection, received a new indication from the FDA on Dec. 9, 2022. It now is indicated as monotherapy to treat patients at least two years old who have alveolar soft part sarcomas (ASPS) that have spread or that cannot be removed by surgery. An extremely rare type of cancer diagnosed for fewer than 100 Americans each year, ASPS begins as a painless lump in soft tissue, such as muscles or nerves – generally in the face for children or in a leg for adults. It produces blood vessels, which allow it to spread easily and quickly. In the phase II clinical trial, about one-fourth of the 49 treated patients had a response to Tecentriq. Responses lasted an average of at least 12 months for around 40% of the responders. To treat children and teens who have ASPS, Tecentriq is infused intravenously (IV) once every three weeks at a dose of 15mg/kg with an upper limit of 1,200mg per infusion. For adult patients, it can be administered once every two weeks at 840mg, once every three weeks at 1,200mg, or once every four weeks at 1,680mg. Other indications for Tecentriq, usually along with other oncology drugs, include some liver cancers, melanomas, non-small cell lung cancers (NSCLC), and small cell lung cancers (SCLC). Check here for its revised prescribing information.
Labeling Updates for Capecitabine
The FDA’s Oncology Center of Excellence has begun a pilot program, Project Renewal, to analyze real-world evidence (RWE) for cancer drugs that were FDA-approved before 2005, when the present format and content standards for prescription drug labels were established. Together with drug manufacturers, independent practicing oncologists, and clinicians in related fields, such as pharmacology, oncology fellows who are beginning their careers critically evaluate publically available information to document support for drug uses that currently are not included in the product labeling. Typically, brand drug manufacturers do not seek FDA approval for new indications once their products have lost patent protection. On Dec. 14, 2022, the FDA announced its approval of significant labeling changes for capecitabine (Xeloda® Genentech) tablets, the first drug assessed under Project Renewal. Originally approved by the FDA in 1998, Xeloda was the first oral drug indicated for treating metastatic breast cancer. Later, it was approved for colorectal cancer (CRC), as well. The first generics for it were launched in 2014. Based on the Project Renewal Team’s review of published literature, the FDA has expanded both prior indications and added new ones for some types of gastric, esophageal, or gastroesophageal junction cancers and certain pancreatic cancers. In addition, some dosage recommendations for capecitabine were changed or incorporated, patient counseling suggestions were updated and a boxed warning about the chance of excessive bleeding if Xeloda is taken at the same time as a vitamin K antagonist was revised. Other information also has been edited and reformatted. Complete updated prescribing information for Xeloda may be found here. For more about Project Renewal, look here.
Authorized Generic to Folotyn Launched
On Dec. 8, 2022, Fresenius Kabi announced that it has launched pralatrexate injection, an authorized generic to Acrotech Biopharma’s Folotyn® in the United States. It blocks the activity of dihydrofolate reductase to treat adult patients who have relapsed or refractory peripheral T-cell lymphoma (PTCL). The recommended dose is 30mg/m2 administered as a three-to-five-minute intravenous (IV) injection once every week for six weeks. After one week with no pralatrexate, the seven-week cycle begins again. Because using it may suppress blood cell formation and/or cause liver damage, patients will need frequent blood tests and liver function checks. It also can cause sores in the mouth, reactions on the skin, and harm to a developing fetus. Patients need supplements of folic acid and vitamin B12 during therapy. Like Folotyn, the generic was given Accelerated Approval by the FDA, which means that results from required clinical trials must prove pralatrexate’s effectiveness before it is fully approved. It is available in single-dose vials containing either 20mg/mL or 40mg/2mL. U.S. sales for Folotyn amounted to about $19.3 million in 2020 according to IQVIA.
Planned Tascenso ODT Launch
Cycle Pharmaceuticals, the U.S. distributor of Handa Neurosciences’ Tascenso ODT® (fingolimod) orally disintegrating tablets, announced that it will launch the new dose form in the first quarter of 2023. The tablets, which were FDA-approved in December 2021, are indicated to treat pediatric patients who are at least ten years old and who weigh 40kg (88 pounds) or less with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS. Given once each day at a recommended dose of 0.25mg, Tascenso ODT tablets are dissolved on the tongue and then swallowed. After the first dose, blood pressure for all patients should be checked every hour for six hours or longer for any signs of bradycardia (possibly dangerous slowing of heartbeats) associated with taking fingolimod. An electrocardiogram is mandatory before the first dose and after the monitoring period ends, as well as regularly during treatment. Other adverse effects may include higher risks of infections, liver damage, and macular edema. Women who may become pregnant should use effective methods of contraception during therapy and for a minimum of two weeks after treatment stops. A 0.5mg Tascenso ODT tablet is under FDA consideration for treating older, heavier patients. Here is prescribing information for Tascenso ODT.
Asceniv and Bivigam Receive FDA Approval for a New Storage Option
ADMA Biologics announced on Dec. 13, 2022, that its IV immunoglobulins (IVIGs), Asceniv™ (immune globulin intravenous, human – slra 10% liquid) and Bivigam® (immune globulin intravenous, human – 10% liquid) now are FDA approved to be stored at room temperature (25˚Celsius or 77˚Fahrenheit) for short periods. Formerly kept only under constant refrigeration, each product now can be held at room temperature for as much as a total of one month during the first 24 months of the product’s 36-month-long shelf life. They both are given by IV infusion to treat primary humoral immunodeficiencies (PIs) – Asceniv for patients as young as 12 years old, and Bivigam for patients who are at least six years old. ADMA believes that allowing some time away from refrigeration will lead to a better distribution of the products in areas that may not have adequate facilities to maintain uninterrupted cold storage with no loss of effectiveness and no impact on the safety of the products. Revised prescribing information for Asceniv will be posted here; for Bivigam, here.