Suflave FDA Approved

Sabela Pharmaceuticals was granted U.S. Food and Drug Administration (FDA) approval on June 15, 2023, for a new osmotic laxative combination that is used to prepare for a colonoscopy. Suflave™ (polyethylene glycol/sodium sulfate/potassium chloride/magnesium sulfate/sodium chloride for oral solution) is indicated to cleanse the colon for adults undergoing a colonoscopy. It will be dispensed in cartons of two packets of lemon-lime flavoring and two bottles that each contain one dose of the powdered drug. On the evening before the procedure is scheduled, one dose (one bottle) and one flavoring packet should be mixed with warm water and consumed as eight ounces every 15 minutes, followed by 16 ounces of plain water. At least four hours later, and five to eight hours before the colonoscopy, the patient should reconstitute and drink the second dose at the same rate and also follow it up with 16 ounces of water. Doses can be refrigerated after mixing to make them easier to take, but they should be used within 24 hours of being diluted. The patient also must follow a strict clear-liquids-only diet after having a low-residue breakfast on the day before the colonoscopy. All liquids should be stopped two or more hours before the procedure. Braintree Laboratories, a subsidiary of Sabela, will introduce Suflave to the U.S. market in August 2023. Numerous other drugs already are available for colonoscopy preparation. Here is its prescribing information.

Lantidra Cell Therapy Approved to Treat Type 1 Diabetes

The FDA granted approval for Lantidra (donislecel-jujn – CellTrans) on June 28, 2023. It is a pancreatic islet cellular suspension indicated for treating adults who have “brittle” (also known as “labile”) type 1 diabetes. Brittle diabetes is difficult to manage due to frequent instances of potentially dangerous hypoglycemia that result from intensive insulin therapy. The American Diabetes Association (ADA) estimates that 1.6 million American adults have type 1 diabetes, an autoimmune disease that requires frequent doses of supplemental insulin. Approximately 0.003% (about 5,000) of them are believed to have the brittle form of the condition. Blood sugar levels for patients who have brittle diabetes can jump or fall rapidly and often unpredictably. Lantidra provides donated pancreatic islet cells that produce more stable levels of insulin. For most patients, it will be given as one intravenous (IV) infusion into the liver’s portal vein. Some patients may need additional infusions. The lowest recommended dose is 5,000 equivalent islet numbers (EIN)/kg for the first procedure and 4,500EIN/kg if follow-up treatments are needed. The infusions must be administered within six hours of their manufacture at CellTrans’ facility in Chicago, Illinois. They will be delivered in operating rooms or radiology suites by specialists – surgeons or interventional radiologists – who have experience with infusing islet cells. Because patients need to take immunosuppressants that prevent rejection of the transplanted beta cells, they may experience serious side effects, such as higher rates of infection and a greater risk of cancer from the drugs. Discontinuing the immunosuppressant results in transplant rejection. At least three other companies are in the earlier stages of developing cell therapies for the same population of patients. Some of them do not use donor cells, so they do not need to be paired with immunosuppressants. The cost and launch date for Lantidra is not yet known. It will be distributed exclusively to hospitals, not through specialty pharmacies. Prescribing information is here.

Liquid Form of Atorvastatin Launched

On June 23, 2023, CMP Pharma revealed its launch of Atorvaliq^® (atorvastatin) Oral Suspension, which was FDA-approved in February 2023. The first commercially available liquid atorvastatin product, it is indicated along with diet changes to help decrease low-density lipoprotein cholesterol (LDL-C) for adults who have primary hyperlipidemia and for adults and children aged 10 years old and older who have heterozygous familial hypercholesterolemia (HeFH). In combination with other therapies that treat high cholesterol levels, it can be used to treat homozygous familial hypercholesterolemia (HoFH) for patients at least 10 years old. Additionally, it is FDA-approved to lessen the chances of serious adverse cardiovascular (CV) events for adults who have numerous risk factors for coronary heart disease (CHD), whether or not they also have type 2 diabetes and/or clinical signs of CHD. Adults who have primary dysbetalipoproteinemia or hypertriglyceridemia also can use it along with diet changes, as well. Intended for patients who have trouble swallowing tablets, Atorvaliq is available in bottles that contain 150mL (about five ounces) of 20mg/5mL orange-flavored suspension. Once-daily doses start at 10mg or 20mg for patients of any age, with a recommended upper limit of 20mg/day for children and teens and 80mg/day for adults. It should be drawn up into an oral syringe and taken one hour or more or at least two hours after ingesting any food. According to GoodRx, one bottle of Atorvaliq retails for approximately $200. Look here for complete prescribing information.

Humira Biosimilars

Under settlement agreements with AbbVie, several biosimilars to Humira^® (adalimumab) injection will be allowed to launch on July 1, 2023. Amgen introduced the first one, Amjevita^™ (adalimumab-atto) injection for subcutaneous (SC) use, to the U.S. market in January 2023, and others may be released later in the year. Most of the biosimilars are approved for treating the same major inflammatory conditions as Humira – adult ankylosing spondylitis, plaque psoriasis, psoriatic arthritis (PsA) rheumatoid arthritis (RA), and ulcerative colitis (UC), as well as pediatric and adult Crohn’s disease and polyarticular juvenile idiopathic arthritis (pJIA). Like all drugs that block the activity of tumor necrosis factor (TNF), biosimilars for Humira have boxed warnings outlining the increased chances that cancer and serious infections may be associated with their use. Prospective patients also should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. For more information, please see the “Humira Biosimilars” Issues Document, which is attached.

MedWatch Update

Oxandrin/Oxandrolone

On June 28, 2023, the FDA officially withdrew its marketing approval for the anabolic steroid, Oxandrin^® (oxandrolone – Gemini Laboratories), and all of its generic equivalents (from Par Pharmaceuticals, Sandoz, and Upsher-Smith Laboratories). Starting in the 1960s, they were approved to promote weight gain after significant health-related weight loss, to counteract side effects from lengthy treatment with corticosteroids, and to relieve bone pain due to osteoporosis. Their possibly severe side effects, which include some types of hepatitis, liver failure, intra-abdominal hemorrhage, high blood levels of calcium, and prostate conditions, caused all of the manufacturers to request that their approvals be withdrawn. All have stopped marketing their products. More information is in a Federal Register notice here.