Injector Device Approved for Empaveli
On Sept. 28, 2023, Apellis Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval for Empaveli® (pegcetacoplan) Injector. A targeted inhibitor of complement 3 (C3), Empaveli was FDA approved in May 2021 to treat adult patients who have paroxysmal nocturnal hemoglobinuria (PNH). It is given as twice weekly 1,080mg subcutaneous (SC) infusions. Previously, it had to be given through an infusion pump, but the new, self-contained device adheres to the patient’s abdomen allowing for greater mobility during injections. After filling the device’s reservoir with Empaveli, the patient or caregiver pushes the start button, and the device automatically delivers the dose over 30 minutes to 60 minutes, the button pops up and the device shuts itself off after retracting the short needle used to administer the drug. The device then can be discarded in a sharps container. Patients should be careful not to fall asleep or get the device wet during drug administration. It is anticipated to be introduced to the U.S. market by the end of October. No information is available about its cost. Empaveli has a risk evaluation and mitigation strategy (REMS), a boxed warning, and a patient Medication Guide informing about potentially life-threatening bacterial infections that may occur during its use. Vaccinations against bacterial infections must be given at least two weeks before beginning Empaveli therapy. For more information about the new delivery device, look here. For complete prescribing information, look here.
Technegas FDA Approved
As a new dosage form, Cyclopharm’s Technegas® (kit for the preparation of technetium Tc 99mlabeled carbon inhalation aerosol) was FDA-approved on Sept. 30, 2023, for patients as young as six years old. Considered to be a drug-device combination product, it is an inhaled radioactive imaging agent that will be used along with perfusion imaging to assess pulmonary embolisms and alone to examine pulmonary ventilation patterns. Using patented equipment that Cyclopharm will install at the imaging facility, sodium pertechnetate Tc 99m Injection is mixed with highly purified argon gas. The mixture must be inhaled through a specialized mouthpiece, also supplied by Cyclopharm, within 10 minutes. Technegas must be handled by professionals who are trained and certified in the safe use of radioactive materials, including proper disposal. A similar, but non-radioactive product, Polarean Imaging’s Xenoview™ (xenon Xe 129 hyperpolarized) was approved by the FDA for oral inhalation on Dec. 23, 2022. To be used with magnetic resonance imaging (MRI), it also is a unique drug-device combination product that measures lung function for patients as young as 12 years old who are being considered for procedures such as lung transplants. No cost information has been announced for Technegas, which is expected to be available in early November. Check here for its prescribing information.
Pediatric Indication for Zoryve
The indication for Zoryve® (roflumilast) Cream 0.3%, was extended by the FDA on Oct. 5, 2023, to include children aged six years and older. Arcutis Biotherapeutics initially received FDA approval in July 2022, for the topical phosphodiesterase-4 (PDE4) inhibitor to treat all severity levels of plaque psoriasis for patients who are at least 12 years old. Clinical trial results show that it reduces symptoms of psoriasis, including in the hard-to-treat intertriginous areas, which are places where two skin surfaces come into contact, such as in the bends of the elbows and knees. Zoryve is rubbed into affected areas of skin once a day, avoiding contact with the eyes, mouth, and vagina. It can be used continuously as long as needed. Updated prescribing information is here.
Second Interchangeable Biosimilar for Humira
Abrilada™ (adalimumab-afzb) injection, Pfizer’s low-concentration, a citrate-free biosimilar to Humira (adalimumab – AbbVie) was approved by the FDA in November 2019. On Oct. 4, 2023, it became the second biosimilar to be FDA-approved as interchangeable with Humira, meaning that it automatically can be substituted for Humira in states that allow direct substitution. A tumor necrosis factor (TNF) inhibitor that helps to inhibit inflammation, Abrilada is indicated to treat a number of inflammatory conditions including ankylosing spondylitis (AS), adult Crohn’s disease, hidradenitis suppurative (HS), juvenile idiopathic arthritis (JIA), plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) and ulcerative colitis (UC). Generally, it is given once every other week as a subcutaneous (SC) injection at doses that vary according to the condition being treated. A boxed warning on the labels of all TNF blockers outlines the increased risks of cancer and serious infections that may be associated with their use. Patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Pfizer expects to launch Abrilada during October at a wholesale acquisition cost (WAC) 5% below the WAC for Humira. Later in the year, it also will be offered at 60% less. Presently, Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), which was introduced to the U.S. market in July 2023, is the only other biosimilar that is interchangeable with Humira. Check here for Abrilada’s full prescribing information.
Interchangeability Approved for Byooviz
A biosimilar to Genentech’s Lucentis® (ranibizumab), Byooviz™ (ranibizumab-nuna) was introduced in the U.S. in July 2022. On Oct. 3, 2023, it was approved for interchangeability with Lucentis. Another interchangeable biosimilar, Cimerli® (ranibizumab-eqrn – Coherus BioSciences) injection was released on the U.S. market about one year ago. Byooviz has three of the same indications as Lucentis and Cimerli – neovascular (wet) age-related macular degeneration (AMD), macular edema that results from retinal vein occlusion, and myopic choroidal neovascularization (mCNV). Lucentis and Cimerli have additional approvals to treat diabetic macular edema (DME) and diabetic retinopathy (DR). By blocking vascular endothelial growth factor (VEGF), they decrease the formation of and seepage from blood vessels in the eyes. Doses are administered by an eye care specialist as 0.5mg injections directly into the affected eyes once a month. After three or four months, some patients may be able to receive shots at longer intervals, such as once every three months, but outcomes may not be as favorable. In a head-to-head clinical trial between Byooviz and Lucentis, patients in both treatment groups had comparable results. Byooviz’s current prescribing information is here.
New Novavax COVID-19 Vaccine Formulation Authorized
The FDA updated the emergency use authorization (EUA) for Novavax’s adjuvanted COVID-19 vaccine on Oct. 3, 2023. The vaccine’s version for 2023-2024 has been modified to provide better coverage against more recent strains of the virus than those included in the vaccine’s original formulation, which is no longer authorized for use by the FDA. Administered as an intramuscular (IM) injection by a healthcare professional, Novavax’s vaccine provides an alternative for individuals who are at least 12 years old and who cannot use one of the mRNA-based COVID-19 vaccines. One dose of the Novavax vaccine is recommended for those who have had any prior vaccination for COVID-19, but previously unvaccinated individuals will need a second dose given three weeks after the first one. Here is more information, including links to revised Fact Sheets for Novavax Adjuvanted (2023-2024 Formula).
Exkivity Being Withdrawn
After a required post-marketing study failed to support the effectiveness of Exkivity® (mobocertinib), Takeda has decided to remove the tyrosine kinase inhibitor (TKI) from the market. Given the FDA’s Accelerated Approval in September 2021, it was the first oral therapy indicated to treat adults who have locally advanced or metastatic non-small cell lung cancer (NSCLC) that has epidermal growth factor receptor (EGFR) exon 20 insertion mutations and that has progressed during or after platinum-based chemotherapy (chemo). In the study, Exkivity did not outperform standard chemo for improving progression-free survival (PFS) rates for patients. Takeda is collaborating with the FDA, other regulatory groups, and healthcare professionals to ensure that patients currently taking Exkivity can continue therapy with it or transition to alternative treatments. New patients will not be started on it, however.
On Sept 27, 2023, KVK-Tech escalated a previous wholesale-level recall to the consumer level. After one tablet of another drug was found in a bottle of betaxolol tablets, 20mg, the entire lot was recalled. Betaxolol is a beta blocker used orally to treat hypertension. Missing doses of it could jeopardize the control of blood pressure. Taking unknown other drugs could lead to unexpected effects and/or side effects. Here is more information.
Scynexis recalled two lots of Brexafemme® (ibrexafungerp) tablets to the consumer level on Sept. 27, 2023, because the raw material used to produce the tablets may contain a contaminant. Brexafemme is an oral antifungal drug dispensed in four-tablet blister packs to treat and prevent vaginal candidiasis. The contaminant could result in hypersensitivity reactions that could be fatal. The FDA notice can be found here.