| Eohilia Receives FDA Approval The U.S. Food and Drug Administration (FDA) approved Eohilia (budesonide oral suspension – Takeda Pharmaceutical Company) on Feb. 9, 2024. It is a new formulation of a corticosteroid that is used to treat a variety of conditions. Eohilia is indicated to treat eosinophilic esophagitis (EoE) in patients who are at least 11 years old. Estimated to affect about 106,000 patients in the United States, EoE is a chronic allergic/immune condition that causes inflammation and constriction of the esophagus. Around two-thirds of patients are male and the highest numbers of cases are diagnosed between the ages of 25 years old and 50 years old. Because swallowing can be difficult for patients who have EoE, Eohilia uses a proprietary method of manufacturing to give it a thin texture when it is shaken, but a thicker texture that coats the inside of the esophagus when swallowed. Its recommended dose is 2mg (one “stick” container) taken twice a day for 12 weeks. It will be dispensed in boxes that contain 60 individual cherry-flavored sticks. Launch is planned by the end of February 2024 at a wholesale acquisition cost (WAC) of $1,875 per box. Although many other drugs, including other dose forms of budesonide, are used off-label to treat EoE, the only other drug FDA-approved to treat it is Dupixent® (dupilumab) subcutaneous (SC) injection. Full prescribing information is here. First Drug Approved to Treat Frostbite Aurlumyn™ (iloprost) injection, was FDA approved on Feb. 13, 2024. Made by the Eicos Sciences subsidiary of CiVi Biopharma, it is the first drug indicated to treat adults who have severe frostbite. A prostaglandin, dilates blood vessels, lessens blood clotting, and fights inflammation to help prevent amputations that often are needed for frostbite-damaged parts of the body. The worst form of frostbite causes the skin and underlying tissues, including blood vessels to freeze, which stops blood flow – typically in peripheral areas such as the ears, fingers, nose, and toes. When the areas are rewarmed, blisters may form and dead skin and tissue turn black. Some dead tissue may need to be removed partially by surgery, or completely by amputation. Patients usually need pain relievers and some may require antibiotics and/or anticoagulants. A clinical study measured Aurlumyn’s effectiveness for adults who had severe frostbite. None of the 16 patients who received Aurlumyn as intravenous (IV) infusions for six hours a day for as long as eight days needed any amputations of fingers or toes as compared to three patients (of 16) who got Aurlumyn plus one of several other drugs and nine (of 15) given only other drugs, not Aurlumyn. All the patients also got 250mg/day of IV aspirin therapy. The recommended dose of Aurlumyn is 0.5ng to 2ng/kg/minute given as a six-hour IV infusion for up to eight straight days. To be launched during the spring of 2024, it will be packaged in single-dose vials containing 100mcg (100,000ng). In clinical trials, frequent side effects included dizziness, fast heartbeats, headache, nausea, and vomiting. Because using Aurlumyn may cause hypotension, blood pressure should be checked frequently during therapy with it. Designated as an Orphan Drug, Aurlumyn was approved under the FDA’s Priority Review process. A previously FDA-approved form of iloprost, Ventavis® (Actelion Pharmaceuticals), is inhaled to treat pulmonary hypertension (PAH). Look here for Aurlumyn’s prescribing information. Extended Indication for Onivyde Approximately 66,000 Americans will be diagnosed as having pancreatic cancer each year, according to the American Cancer Society (ACS). With many cases being in advanced stages before they are discovered, the chance of living for five years is only around 3%. On Feb. 13, 2024, the FDA expanded the indication for Onivyde® (irinotecan liposomal injection – Ipsen Biopharmaceuticals) using Fast Track review. It originally was approved by the FDA in October 2015, in combination with chemotherapy (chemo) using fluorouracil (5-FU) and leucovorin to treat advanced pancreatic cancer for patients who previously had received therapy with gemcitabine. Now, it is indicated for initial use to treat advanced pancreatic cancer, but it should be used only in combination with 5-FU, leucovorin, and oxaliplatin – a regimen known as NALIRIFOX. Recommended dosing has lowered, as well. For first-line use, it is administered at 50mg per square meter (m2) of body surface area by IV infusion once every two weeks, followed by the chemo drugs. For previously treated patients, the dose remains at 70mg/m2 on the same schedule. Patients also should receive an anti-nausea drug and dexamethasone one-half hour before each 90-minute infusion of Onivyde. Labeling for it has a boxed warning that it may cause severe neutropenia (low levels of white blood cells that fight infections) and/or severe diarrhea. Although several other irinotecan drugs are available, none can be substituted for Onivyde. Here is its revised prescribing information. Generic Approved for Emflaza Aurobindo Pharma received approval from the FDA on Feb. 9, 2024, for generics to the specialty drug, Emflaza® (deflazacort – PTC Therapeutics) tablets in 6mg, 18mg, 30mg, and 36mg strengths. With once-daily doses determined by the patient’s body weight, it treats Duchene muscular dystrophy (DMD) for patients who are at least five years old. Introduction to the U.S. market is planned before March 1, 2024, but price information is not yet available. In a corporate presentation, PTC Therapeutics estimated that net revenue from Emflaza was about $255 million in 2023. Recall On February 5, 2024, Retractable Technologies, Inc. announced the recall of one lot of EasyPoint Needles after it was determined that possible detachment of the needle cannula from the needle holder could result in serious injury if it detaches from the needle holder while in the patient. EasyPoint Needles are retractable needles that attach to Luer Lock or Luer slip syringes for intramuscular (IM) injection. The recall notice is here. |
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