Penmenvy Approved to Prevent Five Meningococcal Serotypes
On. Feb. 14, 2025, the US Food and Drug Administration (FDA) approved Penmenvy™ (meningococcal groups A, B, C, W, and Y vaccine – GSK) indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 years through 25 years of age. This vaccine merges the vaccine coverage of Bexsero® (MenB – GSK) and Menveo® (MenACWY – GSK) and has demonstrated non-inferiority to the vaccination for both vaccines, combined, for all five Neisseria meningitides serogroups (A, B, C, W, and Y) in terms of immune response. The vaccine has also shown a safety profile consistent with Bexsero and Menveo. Single-dose vaccines help streamline the vaccination process, reduce the number of injections and ensure full vaccination against all the US Centers for Disease Control and Prevention (CDC)-recommended serogroups. Meningococcal disease, while uncommon, is a serious illness that can lead to death within 24 hours and significant long-term disabilities for survivors. Penmenvy is administered as two intramuscular injections, requiring reconstitution at the time of administration, given six months apart. Here is the prescribing information.
Prolia and Xgeva Get Second Interchangeable Biosimilars
The FDA approved Samsung Bioepis’ biosimilars for Amgen’s receptor activator of nuclear factor kappa beta ligand (RANKL) inhibitor, denosumab on Feb. 13, 2024. Ospomyv™ (denosumab-dssb; 60mg pre-filled syringe) injection is interchangeable with Prolia® (denosumab), and Xbryk™ (denosumab-dssb; 120mg vial) can be interchanged with Xgeva® (denosumab). Ospomyv is indicated for the treatment of osteoporosis for those at high risk for fracture in certain populations like men, post-menopausal women and those taking glucocorticoids or certain drugs for prostate and breast cancer. It is administered by a healthcare provider as a 60mg subcutaneous (SC) injection once every six months. A boxed warning and a risk evaluation and mitigation strategy (REMS) caution that using Prolia may raise the risk of dangerous hypocalcemia (low levels of calcium in the blood) for patients who have chronic kidney disease (CKD). Xbryk is indicated to prevent skeletal-related events for some patients who have multiple myeloma, bone metastases from solid tumors, giant cell tumors of the bone or hypercalcemia of malignancy. After loading doses, it is administered SC at 120mg once every month by a healthcare provider. Jubbonti® (denosumab-bbdz – Sandoz), the first biosimilar to Prolia and Wyost® (denosumab-bbdz – Sandoz) the first biosimilar to Xgeva, were approved on March 5, 2024; however, due to a settlement agreement cannot launch until May 31, 2025, and will hold interchangeability exclusivity until Oct. 29, 2025. Launch for Ospomyv and Xbryk is dependent on pending litigation. For prescribing information, please refer to the respective links for Ospomyv and Xbryk.
Second Vaccine for Chikungunya Approved
On Feb. 14, 2025, the FDA granted accelerated approval to Vimkunya™ (chikungunya vaccine, recombinant – Bavarian Nordic) to prevent infection with chikungunya virus (CHIKV) in patients who are at risk for infection either by living in or traveling to a place where the virus is common. Although this is the second vaccine approved to prevent infection with CHIKV, this is the first indicated for people aged 12 years and older. Already widespread in tropical and subtropical areas of Africa, the Americas and Asia, the prevalence of CHIKV is increasing in locations that are heating due to climate change. It is spread by mosquitos and has symptoms, such as fever, headaches and muscle pain that are similar to those of some other viral illnesses. It may also cause severe joint pain that may last for extended periods. No specific treatment presently is available for CHIKV. Given as a single intramuscular (IM) injection, Vimkunya is a virus-like particle vaccine, not a live-attenuated vaccine like the previously approved Ixchiq. The launch is expected in the first half of 2025. The prescribing information may be found here.
Recall
Fentanyl Transdermal Recalled On Jan. 31, 2025, Alvogen, Inc. issued a recall for one lot to the consumer level for Fentanyl Transdermal System 25 mcg/h transdermal patches. The patches are packaged in a single product pouch where they can be adhered to one another or multi-stacked. There is a risk of too high of a dose than what is intended, resulting in respiratory depression or death. Fentanyl is a potent opioid used for the management of severe or persistent pain in patients who have a tolerance for opioids and require extended daily use or in which alternative pain treatment options are not adequate. Patients with affected patches should immediately remove them and contact their healthcare prescriber. Additionally, they should return unused patches to the dispensing pharmacy. For additional information see, here.