iDose TR Receives FDA Approval

Glaukos Corporation received U.S. Food and Drug Administration (FDA) approval for iDose^® TR (travoprost intracameral implant), 75mcg, on Dec. 13, 2023. It is a prostaglandin analog that decreases intraocular pressure (IOP) for patients who have ocular hypertension (OHT) or open-angle glaucoma (OAG). Several other prostaglandin products are available for the same indication, but they all are in the form of eye drops that must be used daily. In contrast, iDose TR delivers travoprost continually for as long as three years. Prostaglandins are thought to work by increasing drainage of fluid from layers of the eye. Each iDose TR is pre-loaded into an insertion device containing a very small titanium capsule that gradually releases the drug at a fixed rate. The container is inserted into the sclera (the outer part of the eyeball) by an ophthalmology specialist under sterile conditions. Patients should be checked periodically to be sure the implant remains where it was placed. In its clinical studies, the effects of iDose TR were comparable to those of timolol, a twice-daily beta-blocker eye drop widely used to lower IOP. Treatment side effects were similar, as well. Patients in both treatment groups reported generally mild and temporary changes such as blurry vision, eye dryness, and iris irritation. Unlike other drug classes used to decrease IOP, prostaglandins may permanently change the patient’s eye color to brown. With an introduction to the U.S. market planned for late in the first quarter of 2024, the wholesale acquisition cost (WAC) of each iDose implant is $13,950. Look here for its prescribing information.

New Indication for Welireg

Welireg^® (belzutifan – Merck) tablets were approved by the FDA for a new indication on Dec. 14, 2023. Currently, it is the only approved drug in the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor therapy class. HIF-2α is a protein that helps to regulate oxygen levels throughout the body. Excessive amounts of it send false signals that blood oxygen levels are low. New blood vessels are created, red blood cell (RBC) levels increase and tumors form. By interfering with HIF-2α, Welireg decreases blood vessel and RBC overproduction. It also reduces the production and spread of tumor cells. Welireg now is indicated to treat adults who have renal cell carcinoma (RCC) that has progressed despite treatment with a programmed death receptor-1 (PD-1) inhibitor or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). RCC is diagnosed in around 74,000 Americans annually, as estimated by the American Cancer Society (ACS). In the LITESPARK-005 clinical study, the overall response rate (ORR) among patients taking Welireg was 22% versus only 4% for participants taking everolimus tablets, an immunosuppressant commonly used as standard therapy for advanced RCC. It was first FDA-approved in 2021 to treat patients who have RCC and other cancers associated with a rare genetic disease, von Hippel-Lindau (VHL) syndrome, which causes cancerous and non-cancerous tumors in various parts of the body. To treat both of its indications, the recommended dose of Welireg is 120mg (three tablets) once a day. A boxed warning cautions that taking Welireg can damage an unborn baby, so women should not take it if they are pregnant. Because using it can disrupt hormonal forms of contraception, women of childbearing age also should use a reliable non-hormonal contraceptive during treatment. Other common side effects include blood abnormalities, electrolyte imbalances, and elevated liver enzymes. Updated prescribing information may be found here.

Nexletol/Nexlizet Indication Modified

Esperion’s once-daily adenosine triphosphate (ATP) citrate lyase (ACL) inhibitor, Nexletol^® (bempedoic acid) tablets, and its combination with ezetimibe, NEXLIZET^® tablets, originally were FDA approved in 2020. At that time, they were indicated, in addition to diet alterations, to treat adults who have heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) and who already were taking the highest allowable dose of an HMG-CoA reductase inhibitor (statin), but who still required additional lowering of LDL cholesterol (LDL-C). On Dec. 13, 2023, the FDA eliminated those restrictions – approving both drugs, with diet and any dose of a statin, for treating primary hyperlipidemia in adults who still have high LDL-C along with HeFH or ASCVD. Bempedoic acid works by reducing the liver’s production of cholesterol and by increasing the activity of LDL-C receptors. Both effects decrease the amount of LDL-C in the blood. Taking bempedoic acid may raise blood levels of uric acid and increase the risk of ruptured tendons. Some patients may have hypersensitivity reactions to ezetimibe. More common side effects include anemia, bronchitis, fatigue, sinusitis, upper respiratory infections, and abdominal, back or joint pain. Prescribing information for Nexletol is here; for Nexlizet, here.

Vabysmo Granted a New Indication

On Oct. 26, 2023, Genentech’s Vabysmo^® (faricimab-svoa) injection was given a new FDA indication to treat macular edema following retinal vein occlusion (RVO). Approximately one million Americans have RVO, which can destroy vision with little or no warning. Initially, Vabysmo, a bispecific antibody, was FDA approved in January 2022 to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). It blocks the activity of neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), to decrease blood seepage and inflammation in the eyes by strengthening blood vessels. Under sterile conditions, Vabysmo is injected into the affected eyes by a healthcare professional. Separate vials should be used if the patient needs injections in both eyes. For the treatment of RVO-associated macular edema, the recommended dose is one injection (6mg) into each affected eye once every four weeks for a total of six doses per eye. Check here for complete prescribing information.

Pediatric Indication Approved for Cresemba

Cresemba^® (isavuconazonium – Astellas Pharma) was granted FDA approval on Dec. 8, 2023, for treating children who are as young as one year old with its intravenous (IV) form and for treating patients aged at least six years old who weigh 16kg (about 35 pounds) or more with its oral capsules. The IV form also may be used for patients aged six years and older and weighing 16kg or more who need a nasogastric (NG) tube. Previously, it was approved only for use by adults. The antifungal drug is indicated to treat invasive cases of aspergillosis (IA) and mucormycosis (IM), potentially fatal fungal infections that most often affect patients who have conditions that weaken their immune systems. Doses depend on the age and weight of the patient. After initial doses are given every eight hours for the first two days of treatment, dosing switches to once a day until the infection is resolved. In an open-label clinical trial that included 31 patients younger than 18 years old, patients used Cresemba for up to 180 days, with an average length of 55 days. Infections cleared for 54.8% of patients. Frequent side effects among the trial participants included diarrhea, headaches, itching, nausea, and vomiting. Because Cresemba may cause liver damage, patients using it should have liver enzyme testing before beginning treatment and periodically while therapy with it continues. Cresemba’s revised prescribing information is here.

Bivigam’s Pediatric Indication Extended

On Dec. 8, 2023, the FDA broadened the pediatric indication for Bivigam^® (immune globulin intravenous [human] 10% liquid – ADMA Biologicals). Formerly limited to use for patients aged 12 years old and older, it now can be administered to treat primary immunodeficiencies (PI) for children at least two years old. Believed to affect about 80,000 patients in the United States, PI includes a large group of inherited conditions involving diminished or absent immune function. Patients who have one of them are susceptible to having chronic, possibly life-threatening infections. Standard therapy is to replace the missing natural immunoglobulin (IG), usually through IV infusions of immunoglobulin products (IVIG) derived from donated human blood plasma. First approved in 2012, Bivigam was suspended from the U.S. market temporarily due to concerns with the production process and compliance issues with the original manufacturer. After reformulation and sale to a new manufacturer, it was reintroduced in 2019. The recommended dose of Bivigam for patients of any age is 300mg/kg to 800mg/kg infused once every three to four weeks. Frequent dosage and timing adjustments may be needed, depending on individual patient response. Several other IVIG products are FDA-approved to treat PI. All of them carry a boxed warning that they may be associated with blood clots and kidney damage that could result in acute kidney failure. Here is current prescribing information for Bivigam.

Adbry Approved for Pediatric Atopic Dermatitis

The FDA approved Adbry^® (tralokinumab-ldrm – LEO Pharma) injection on Dec. 14, 2023, to treat patients as young as 12 years old for moderate-to-severe atopic dermatitis (AD) that has not been relieved by topical therapies. A monoclonal antibody that inhibits the action of interleukin-13 (IL-13), Adbry blocks the release of inflammatory substances. It has been FDA-approved since December 2021 to treat adults who have AD. For patients under the age of 18 years, the recommended therapy is one 300mg dose followed once every two weeks by a 150mg dose. All doses are given by subcutaneous (SC) injections. Although adults may be able to self-inject using single-dose, prefilled syringes, pediatric patients should be treated or supervised by an adult caregiver. Using Adbry may increase the risk of eye and upper respiratory infections. All patients should be up to date on all the recommended vaccinations for their age groups before beginning treatment with them. Revised prescribing information is here.

Generic for Risperdal Consta Teva has launched risperidone extended-release injectable suspension, the first A-rated generic for Risperdal Consta^® (Janssen). It was approved by the FDA on Dec. 5, 2023, in 12.5mg, 25mg, 37.5mg, and 50mg vials. An atypical antipsychotic drug, it is used as a single agent to treat schizophrenia or in combination with oral lithium or valproate to treat bipolar I disorder. Administered intramuscularly (IM) once every two weeks by a healthcare provider, the recommended dose is 25mg. Antipsychotic labeling has a boxed warning that using them may increase the risk of death for elderly patients who have dementia. No information is available for the pricing of the generic. As noted in financial reports from Janssen’s parent company, Johnson & Johnson, 2022 U.S. sales for Risperdal Consta amounted to about $485 million.