New MMR Vaccine Approved

Priorix [measles, mumps, and rubella (MMR) vaccine, live] was approved on June 3, 2022, by the U.S. Food and Drug Administration (FDA). It is administered as a series of two subcutaneous (SC) injections starting when a child is between 12 months and 15 months old. The second shot is given between the ages of four years and six years. The other FDA-approved MMR vaccine, M-M-R® II (Merck), has the same dosing recommendations. Priorix can be used for a second dose if the child had M-M-R II vaccine, initially. Along with the vaccines for measles, mumps and rubella, Merck’s ProQuad® also includes a vaccine against varicella (chickenpox); it is considered an MMRV vaccine. On the same dosing schedule as Priorix and M-M-R II, ProQuad is indicated for children between the ages of 12 months and 12 years. However, due to a possibly higher chance that very young children could have seizures after MMRV vaccine, the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that children younger than four years old receive separate shots for MMR and chickenpox. Pregnant women, immunocompromised individuals, anyone who has a fever, recent blood transfusion recipients and those who have bleeding disorders are among the patients who should not be immunized with any MMR vaccine. GSK (formerly GlaxoSmithKline) has not announced a release date or pricing details for Priorix.

New Riabni Indication

On June 3, 2022, the FDA approved Riabni™ (rituximab-arrx) injection, Amgen’s biosimilar of Rituxan® (rituximab – Celgene), to be used in combination with methotrexate for treating adult patients who have rheumatoid arthritis (RA) that is not responsive to treatment with a tumor necrosis factor (TNF) agonist. When it was originally FDA approved in December 2019, Riabni received indications only for the treatment of adults who have non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) or granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The monoclonal antibody causes B cells to disintegrate by binding to CD20 proteins on their cell surfaces. Administered as intravenous (IV) infusions, it has to be given by a health professional in a facility equipped to handle the emergency treatment of serious side effects that it may cause. A boxed warning and patient Medication Guide caution about potentially fatal adverse effects, which can include infusion-related reactions, skin and mucous membrane effects, progressive multifocal leukoencephalopathy (PML) and reactivation of hepatitis B. Doses vary according to the condition under treatment. Riabni cannot be interchanged with Rituxan or with either of the other Rituxan biosimilars, Truxima® (rituximab-abbs – Celltrion/Teva) or Ruxience™ (rituximab-pvvr – Pfizer), that are on the U.S. market.

Extended Pediatric Indication for Dupixent

Regeneron and Sanofi received FDA approval on June 7, 2022, to extend an atopic dermatitis indication for Dupixent® (dupilumab) injection. It is the first biological drug to be approved for treating children who are as young as six months old and who have moderate-to-severe forms of the condition. Previously, the minimum age for its use in atopic dermatitis was six years old. However, the National Eczema Foundation (NEF) estimates that up to 90% of atopic dermatitis cases in the U.S. are diagnosed for children younger than six years old. According to the NEF, 9.6 million American children and teens are believed to have atopic dermatitis, with about one-third having moderate-to-severe forms. Roughly one-half of cases appear by the age of six months. For many pediatric patients, symptoms decrease or disappear as the child gets older, but a significant number of cases persist into adulthood. Of the approximately 16.5 million U.S. adults who have the condition, an estimated 75% had it as children. Atopic dermatitis is an autoimmune inflammatory skin disease caused when an overly active immune system disrupts the skin barrier. It results in dryness, itching, rashes and redness, which can lead to tough, leathery patches of skin. Scratching may cause bleeding; broken skin may become infected with bacteria or viruses. Dupixent is an interleukin-4 alpha-receptor (IL-4Rα) blocking antibody that disrupts the inflammatory process. Available in single-dose prefilled syringes and pen devices, it is administered SC either at home by patients or caregivers, or in a healthcare setting by a professional. Doses are given once a month at 200mg for children up to six years old who weigh between 5kg (11 pounds) and 15kg (33 pounds); and 300mg for children who weigh between 15kg and 30kg (66 pounds). It can be used at the same time as a topical corticosteroid, if needed. Just a few weeks ago, Dupixent became the first medication to be FDA approved for treating patients who are at least 12 years old and who have eosinophilic esophagitis (EoE), a chronic immune disease that destroys the esophagus and impairs swallowing function due to inflammation. It also is approved for treating certain types of asthma in patients six years old and older, and for treating adults who have chronic rhinosinusitis with nasal polyposis.

Additional Pediatric Indication Approved for CellCept

Indications for the use of CellCept® (mycophenolate mofetil – Genentech) also have been added by the FDA. On June 6, 2022, it was approved to prevent rejection for children at least three months old who have heart or liver transplants. Available in the United States for more than 25 years, CellCept also is approved for treating adult heart, kidney and liver transplant recipients; as well as for children who have had kidney transplants. For all its indications, it is used along with other immunosuppressant drugs. Doses are twice daily at strengths that vary according to the type of transplant and the age of the patient. CellCept may be given in oral or IV forms. Because it may cause fetal abnormality or death, it has a boxed warning about using it during pregnancy. Further boxed warnings outline the potential for developing certain cancers or severe infections among patients using it.

Viibryd Generics

Accord Pharmaceuticals announced on June 8, 2022, that its vilazodone tablets, 10mg, 20mg and 40mg, are ready to ship in the United States, but pricing was not disclosed. The generic for Viibryd® (Allergan), vilazodone is taken once a day for treating adult patients who have major depression. Other manufacturers have FDA approval for generics, as well, but no information is available about their possible launches. Under a settlement agreement, some of the companies will share 180-day exclusivity. Annual sales of Viibryd are estimated at $602 million.