Interchangeable Biosimilar Approved for Stelara
On Oct. 31, 2023, the U.S. Food and Drug Administration (FDA) gave its approval to Amgen for Wezlana™ (ustekinumab-auub) injection. The first approved biosimilar to Stelara (ustekinumab – Genentech) injection, Wezlana also is interchangeable. In states where pharmacy regulations allow substitution, it can be dispensed instead of Stelara without contacting the prescriber. Ustekinumab is a biologic drug that inhibits interleukins 12 and 23 (IL-12 and IL-23), to interrupt processes involved in chronic inflammation. It is indicated to treat adults who have active Crohn’s disease (CD) or ulcerative colitis (UC). In addition, ustekinumab is approved for patients as young as six years old who have psoriatic arthritis (PsA) or plaque psoriasis that is amenable to phototherapy or systemic therapy. Both products are available in intravenous (IV) and subcutaneous (SC) dosage forms. Doses are based on the patient’s weight. For psoriatic conditions, two initial SC doses are given one month apart, and then treatment switches to one SC injection every three months. Patients who have CD or UC receive one IV infusion followed by SC injections at two-month intervals. Patients who use ustekinumab may be more susceptible to infections, including tuberculosis (TB), and their risk of developing cancer may be increased. Under a settlement agreement, Wezlana can be launched in the U.S. at any time before January 1, 2025. Additional biosimilars to Stelara are expected to launch in 2025. According to Janssen’s parent company, Johnson & Johnson, U.S. sales for Stelara amounted to about $6.4 billion in 2022. For prescribing information click here.
Voquenza Reformulated and Given New Indication
Phathom Pharmaceuticals announced on Oct. 30, 2023, that the FDA has approved a reformulation of vonoprazan tablets, which are included in Voquenza Dual Pak, — a co-packaging of vonoprazan with amoxicillin — and Voquenza Triple Pak (vonoprazan with amoxicillin and clarithromycin). The only FDA-approved drug in its class, vonoprazan is a potassium-competitive acid blocker (PCAB) that reduces stomach acid in a different way than other available drugs do. It was reformulated to minimize the levels of potential nitrosamine impurities that may develop over time. Both of the co-packaged products are indicated for treating adults who have Helicobacter pylori (H. pylori) infections. Each blister package contains a complete 14-day treatment regimen of the oral drugs. According to GoodRx, the retail cost of one Voquenza Triple Pak averages about $875. In one clinical trial of patients who had H. pylori infections without any antibiotic resistance, the vonoprazan regimens were compared to the widely used three-drug combination that includes the proton-pump inhibitor, lansoprazole, with amoxicillin and clarithromycin. With the Voquenza triple therapy performing slightly better, the overall effectiveness of all three active treatments averaged about 80%. In another study of patients who had clarithromycin-resistant H. pylori, both Voquenza combinations were more effective than the triple lansoprazole regimen. In that study, the H. pylori eradication rate was 65.8% for Voquenza triple therapy, 69.6% for Voquenza Dual Pak, and 31.9% for the lansoprazole combination. Side effects, which included diarrhea, headaches, taste disturbances, and vaginal infections, affected small percentages of patients in all of the study groups. Patients taking any drug that includes rilpivirine should not take vonoprazan. Here is the prescribing information for both co-packaged Voquenza products.
On Nov. 1, the FDA approved the reformulated version of Voquenza (vonoprazan) as monotherapy to treat adults who have erosive gastroesophageal reflux disease (GERD), which also is called erosive esophagitis (EE), and heartburn that is associated with it. In a head-to-head clinical trial, patients taking Voquenza had higher percentages of healing and at least comparable relief of heartburn versus lansoprazole. The Voquenza dose for treatment of active cases is 20mg once each day for two months. For maintenance, the dose drops to 10mg/day for as long as six months. The projected wholesale acquisition cost (WAC) is $650 for a 30-day supply of either strength tablet. Voquenza will be launched as a stand-alone drug and the combination packages relaunched in December 2023. Prescribing information for Voquenza is here.
Extended Indication for Orencia
The FDA approved an extension to the indications for Orencia (abatacept – Bristol Myers Squibb) injection on Oct. 30, 2023. Formerly approved to treat PsA only for adults, Orencia now can be used to treat patients who are two years old and older with PsA. Two other indications, for treating moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) and for preventing acute graft versus host disease (aGVHD) after an allogeneic hematopoietic stem cell transplant (HSCT), also include patients at least two years old. Another indication, for treating rheumatoid arthritis (RA), remains limited to adults, only. Dosage strengths and injection schedules depend on the condition being treated and, for PsA, the weight of the patient. As a T-cell co-stimulation modulator, Orencia decreases T-cell activation to suppress immune response and reduce inflammation. In contrast to adults, who may need IV loading doses of Orencia to treat PsA, pediatric patients can be started and maintained on once-weekly SC injections. Orencia should not be used at the same time as the patient is using a biologic disease-modifying antirheumatic drug (bDMARD), such as Humira (adalimumab/biosimilars); another immunosuppressant, such as cyclosporine; or a Janus-associated kinase (JAK) inhibitor, such as Xeljanz (tofacitinib). See current prescribing information for Orencia here.
New Cosentyx Indication
A tumor necrosis factor-alpha (TNFα) blocker, Cosentyx (secukinumab – Novartis) injection, was FDA-approved on Oct. 31, 2023, for treating adults who have hidradenitis suppurativa (HS). With a prevalence of less than 1% in the United States, HS is a chronic inflammatory skin disease characterized by swollen, painful abscesses and lumps — primarily under the breasts, between the buttocks, and around the armpits and groin. Usually diagnosed during adolescence and early adulthood, it affects around three times as many American women as men. Topical antibiotics and corticosteroids typically are used for their initial treatment, with some patients needing oral antibiotics, hormonal therapy, and/or oral retinoids, especially for flares of the disease. To treat HS, the recommended dose of Cosentyx is 300mg given as an SC injection once a week for five doses and then once every month. Some patients may need injections once every two weeks. Also available in an IV formulation, Cosentyx has previous indications for treating ankylosing spondylitis (AS), enthesitis-related arthritis, non-radiographic axial spondyloarthritis, plaque psoriasis, and PsA. Adalimumab is the only other TNFα blocker that is FDA-approved to treat HS. Check here to see the revised prescribing information for Cosentyx.
Keytruda Gets a New Indication
Merck’s Keytruda (pembrolizumab) injection also obtained a new FDA approval on Oct. 31, 2023. The programmed death receptor-1 (PD-1) inhibitor now is indicated to be used along with the chemotherapy (chemo) drugs cisplatin and gemcitabine to treat adults who have biliary tract cancer (BTC) that cannot be removed by surgery and/or that have metastasized. Involving the gallbladder and liver as well as the bile ducts, BTC is diagnosed for approximately 20,000 patients – mainly senior adults – in the U.S., annually. The overall five-year survival rate is less than 11%. For treating BTC, the recommended dose of Keytruda is 200mg once every three weeks or 400mg once every six weeks as a 30-minute-long IV infusion given before chemo, if used on the same day. Keytruda has numerous other FDA approvals with and without other cancer drugs for treating various types of non-small cell lung cancer (NSCLC), some kidney cancers; some esophageal, stomach and head and neck cancers; as well as Merkel cell carcinoma, multiple myeloma and non-Hodgkin lymphoma. It also has indications for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers), rather than developing from a particular body tissue. Here is Keytruda’s updated prescribing information.
Leader Eye Drops
Following an Oct. 27, 2023, FDA Safety Communication that warns about potential contamination in a number of over-the-counter (OTC) eye drops, Cardinal Health recalled to the consumer level all lots of five eye drops on Oct. 31, 2023. They all were made by Velocity Pharma and labeled as Leader brand. An FDA inspection had uncovered unsanitary conditions, including positive tests for bacteria, at the manufacturing facility where they were produced. Using the potentially contaminated drops could cause eye infections that could result in partial or complete vision loss. More details about the recall are here.