Combogesic IV Approved
Hyloris Pharmaceuticals was granted approval by the FDA for Combogesic® IV on Oct. 17, 2023. To be administered once every six hours as 15-minute long intravenous (IV) infusions, it contains 1,000mg of acetaminophen and 300mg of ibuprofen per 100mL of injectable solution. Acetaminophen is called paracetamol in other parts of the world. Combogesic is indicated when an IV is required for treating adults who have mild to moderate pain or, along with an opioid, moderate to severe pain. Dosing is restricted to five days or less at a recommended dose of 100mL for patients who weigh 50kg (110 pounds) or more. Patients weighing less are given 2.5mL (15mg of acetaminophen and 4.5mg of ibuprofen) per kilogram of actual body weight. Total daily dosing should not be more than 4,000mg of acetaminophen and 1,200mg of ibuprofen. As soon as the patient is able to swallow oral medications, treatment switches away from the IV form of the drugs. Labeling for Combogesic IV includes boxed warnings that using the acetaminophen component may be associated with liver damage and that ibuprofen may cause blood clots and/or gastrointestinal (GI) injury. It should not be given to patients who are having coronary artery bypasses. Beginning early in 2024, deliveries will go to hospitals through the U.S. distributor, Hikma Pharmaceuticals. The prescribing information is here.
Cabtreo Receives FDA Approval
Cabtreo™, a topical gel that contains clindamycin phosphate, adapalene, and benzoyl peroxide, was FDA-approved on Oct. 20, 2023. The first product to combine antibacterial, retinoid, and bactericidal ingredients, it is indicated to treat acne for patients aged 12 years and older. Patients will apply a thin layer of Cabtreo to clean, dry skin once a day, avoiding the eyes, mouth, and mucous membranes. The Ortho Dermatologics unit of Bausch Healthcare plans to launch Cabtreo in 20gm and 50gm pump devices during the first quarter of 2024. Its cost is not yet known. Because clindamycin can cause colitis (inflammation of the colon), Cabtreo should not be used for patients who have colitis or enteritis (inflammation of the small intestine). Patients applying Cabtreo should use sunscreen due to potentially increased ultraviolet (UV) light sensitivity that also may be related to using clindamycin. Look here for prescribing information.
Zymfentra Approved for Inflammatory Bowel Diseases
A new dosage form of infliximab, Zymfentra™ (infliximab-dyyb) injection, was approved by the FDA on Oct. 20, 2023. It is indicated only for the maintenance treatment of adults who have Crohn’s disease (CD) or ulcerative colitis (UC). Unlike other FDA-approved infliximab products that all are given by IV infusions, Zymfentra is administered subcutaneously (SC) at a recommended dose of 120mg once every two weeks. However, patients must have completed a ten-week-long course of therapy with an IV infliximab before being switched to the SC version of the drug. Zymfentra will be marketed in single-dose, prefilled syringes, and pen devices that can be self-administered, likely moving cost into pharmacy benefits from medical coverage. Its manufacturer, Celltrion, is not revealing cost, distribution, or market release details until closer to its launch. A boxed warning for all drugs in its class, tumor necrosis factor-alpha (TNFα) blockers, cautions that using them may raise the risk of serious infections, including tuberculosis (TB). If they are used by children or teens, the risk of lymphoma and other cancers may go up, as well. A Medication Guide that accompanies every Zymfentra prescription outlines its potential risks for patients. Presently, Zymfentra is not approved for treating other inflammatory conditions and it is not interchangeable with any other infliximab product, including Pfizer/Celltrion’s IV biosimilar to Remicade® (infliximab – Janssen Biotech), Inflectra® (infliximab-dyyb), which entered the U.S. market in November 2016. Here is the prescribing information for Zymfentra.
New Meningitis Vaccine Approved
On Oct. 20, 2023, the FDA approved Pfizer’s Penbraya™ (meningococcal groups A, B, C, W, and Y vaccine) suspension for intramuscular (IM) injection. Indicated to prevent infection with the five most prevalent strains of meningococcus for individuals between the ages of 10 years old and 26 years old, it contains strains of the bacterium that previously were available only in two different vaccines. It is given in two doses spaced six months apart. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met on October 25, 2023, to consider placement for Penbraya in the schedule of recommended vaccines. Penbraya’s prescribing information is here.
Voxzogo Indication Expanded
The FDA approved the use of Voxzogo™ (vosoritide – BioMarin Pharmaceutical) for injection on Oct. 20, 2023, to treat achondroplasia (abnormally short stature) for younger children. Originally granted FDA Accelerated Approval in October 2021, it was indicated for treating children who are at least five years old and whose epiphyses (bone growth plates) have not yet closed. Now, the indication includes children who are under the age of five years old. Achondroplasia is caused by mutations in fibroblast growth factor receptor 3 (FGFR3) genes that result in shortness. Characteristics of achondroplasia are due to malformation of bones. They include overall shortness (usually under five feet adult height), short arms, short bowed legs, spinal curvature, and unusually large heads with bulging foreheads and flattened facial areas (frontal bossing). Individuals who have it also may have breathing and lung conditions, such as sleep apnea, mainly resulting from narrow upper airways and small ribcages. Voxzogo is a C-type natriuretic peptide (CNP) analog that blocks FGFR3 receptors, helping to reduce the activity of FGFR3 for children whose bones have not yet stopped growing. With recommended doses ranging from 0.096mg to 0.8mg based on the patient’s weight, it is administered as SC injections once a day. To lower the chance that an injection will cause low blood pressure, patients should have a meal or snack and drink 240mL to 300mL (eight to 10 ounces) of liquid within one hour before receiving Voxzogo. Height, weight, and general physical growth should be measured every three to six months during treatment. BioMarin estimates that approximately 800 children under the age of five years are affected by achondroplasia in the U.S. Updated prescribing information is here.
New Indication for Tibsovo
Tibsovo® (ivosidenib – Sevier Pharmaceuticals) tablets were granted a new indication on Oct. 24, 2023. It now is indicated for treating individuals who have a myelodysplastic syndrome (MDS) that has mutations in isocitrate dehydrogenase 1 (IDH1) and that have returned despite previous therapy or have become resistant to treatment. As the first IDH1 inhibitor, Tibsovo initially was FDA-approved in July 2018 for treating adults who have relapsed or refractory acute myelogenous leukemia (AML) confirmed as having IDH1 mutations. Later, it also was approved alone to treat advanced stages of IDH1-mutated cholangiocarcinoma (cancer in the bile ducts) and – alone or along with azacitidine injection — as initial treatment for new cases of IDH1-positive AML in patients who are at least 75 years old or who have coexisting medical conditions that prevent induction doses of chemotherapy (chemo). It is taken once daily at a dose of 500mg (two tablets). Labeling for it includes a boxed warning about differentiation syndrome, a potentially fatal condition caused by very fast production of immature myeloid cells that may be associated with taking Tibsovo. Patients, caregivers, and prescribers should watch for other possibly serious side effects such as QT interval prolongation and Guillain-Barré syndrome. Another IDH1 blocker, Rezlidhia™ (olutasidenib – Rigel Pharmaceuticals) capsules is approved only for the treatment of adults who have IDH1+ AML that has returned or become unresponsive to previous therapy. Check here for Tibsovo’s revised prescribing information.
Extended Pediatric Indication and New Dosage Form for Rozlytrek
Rozlytrek™ (entrectinib – Genentech) capsules selectively block tropomyosin receptor kinases (TRK) A, B, and C to treat cancers that test positive for neurotrophic tyrosine receptor kinase gene fusions (NTRK+). It was granted the FDA’s Accelerated Approval in August 2019 to treat patients at least 12 years old who have solid tumors with NTRKgene fusions, but not acquired resistance mutations. The tumors also must have metastasized or progressed despite previous treatment. Patients also must risk serious morbidity if the cancer is removed surgically and/or have no other treatment options. On Oct. 20, 2023, the indication was extended to children as young as one month old. Doses for pediatric patients are based on body surface area (BSA). To make dosing easier for children and other patients who have trouble swallowing whole capsules, the FDA also approved a new oral pellet dosage form for Rozlytrek. It will be dispensed in packets that contain 50mg of the drug pellets, which can be sprinkled onto a soft food, such as pudding, for administration. A previous oral capsule formulation can be suspended in water or milk for use by individuals who cannot swallow foods or who need a feeding tube. Because Rozlytrek also inhibits the proto-oncogene, ROS1, it has a second FDA indication for treating adults who have metastatic ROS1 positive (ROS1+) non-small cell lung cancer (NSCLC). For either indication, the recommended adult dosage is 600mg once a day. No information is available, yet, on the pricing or release date for the pellets. Current prescribing information is here.
Vabysmo Approved for Third Indication
The FDA approved a new indication for Vabysmo® (faricimab-svoa – Genentech) injection on Oct. 26, 2023. Previously indicated for treating neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), it now also can be used for relieving macular edema after retinal vein occlusions (RVO). Caused by obstructions in the veins that drain blood from the retinas, RVO results in vision loss that can be permanent. A bispecific antibody, Vabysmo 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. Doses of 6mg are given by an eye care professional as intravitreal injections once every four weeks. For its new indication, Vabysmo is used for six months, only. About 7% of patients using Vabysmo in clinical trials had temporary hemorrhages in the conjunctiva (the membrane lining the fronts of the eyes and the eyelids) making the white parts of the eye look red. Other mostly mild and short-term side effects included eye pain, floaters, and increased intraocular pressure (IOP). Here is the revised prescribing information.
First Generics Approved for Votrient
Apotex has announced that the FDA gave it approval for pazopanib tablets, the first generic for Votrient® – Novartis). Other generic companies may have FDA approval, as well. The kinase-inhibiting drug is indicated for treating adults who have advanced cases of renal cell carcinoma (RCC) or advanced soft tissue sarcoma (STS) that has been treated with chemo. The recommended dose is 800mg (four tablets) taken once daily at least one hour before or two hours after the patient has eaten any food. Pazopanib has a boxed warning because some patients in clinical studies experienced liver damage that was fatal in some cases. Blood levels of liver enzymes and bilirubin should be checked frequently while patients are taking it. Additionally, taking pazopanib may result in blood clotting abnormalities, cardiac issues, GI perforation, lung infections, and other potentially serious adverse effects. Pricing and launch plans are not available for the generic. According to the annual report from Novartis for 2022, sales of Votrient amounted to $474 million for the year.