BeneCard PBF compiles the latest pharmacy news from across the web, including new drug approvals, recalls, new generic drug approvals, and more. The content is the property of the website owners, writers, and contributors.
New Drug Approvals
FLYRCADO
FDA Approves Flyrcado Radioactive Diagnostic for Enhanced Diagnosis of Coronary Artery Disease
September 27, 2024 – GE HealthCare announced the U.S. Food and Drug Administration (FDA) granted approval of Flyrcado (flurpiridaz F-18) injection, a first-of-its-kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD).
- Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today.
- Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improving diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women.
Source: GE HealthCare
COBENFY
FDA Approves Cobenfy, a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in Adults
September 26, 2024 – Bristol Myers Squibb announced the U.S. Food and Drug Administration (FDA) approved Cobenfy (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.
- Cobenfy represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1and M4 receptors in the brain without blocking D2 Schizophrenia is estimated to impact approximately 2.8 million people in the United States. Symptoms typically first appear in early adulthood and present differently.
- While the current standard of care can be effective in managing symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy, making symptoms difficult to diagnose and manage.
Source: Bristol Myers Squibb
AQNEURSA
FDA Approves Aqneursa for the Treatment of Niemann-Pick Disease Type C
September 25, 2024 – IntraBio Inc. announced the U.S. Food and Drug Administration (FDA) approved Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15kg.
- Aqneursa is the only FDA-approved, stand-alone therapy indicated for the treatment of NPC. Until now, current treatment approaches have not addressed the debilitating effects of NPC on patients’ daily lives.
- NPC is a rare, inherited lysosomal disease that occurs in about 1 in 100,000 live births. Patients with NPC typically experience systemic, neurological, and psychiatric symptoms that can be debilitating and significantly impact functional abilities.
Source: IntraBio Inc.
MIPLYFFA™
FDA Approves Miplyffa for the Treatment of Niemann-Pick Disease Type C
Sept. 20, 2024 – Zevra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Miplyffa™ (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC).
- The first NPC drug approved by the FDA, Miplyffa is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.
- Those living with NPC experience progressive physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills.
Source: Zevra Therapeutics, Inc.
EBGLYSS
FDA Approves Ebglyss for the Treatment of Atopic Dermatitis
September 13, 2024 – Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.
- Eczema inflammation under the skin can lead to symptoms seen and felt on the outside. Ebglyss works by targeting eczema inflammation throughout the body that can lead to dry, itchy, and irritated skin.
Source: Eli Lilly and Company
Newly Approved Dosage Forms
OCREVUS ZUNOVO
FDA Approves Ocrevus Zunovo. A Twice-A-Year Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis
September 13, 2024 – Genentech, announced the U.S. Food and Drug Administration (FDA) approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
- Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP) administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.
- Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, with a decade of treatment for multiple sclerosis.
Source: Genentech
TECENTRIQ HYBREZA
FDA Approves Tecentriq Hybreza Anti-PD-(L)1 Cancer Immunotherapy
September 12, 2024 – Genentech announced the U.S. Food and Drug Administration (FDA) approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs). The first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States.
- Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab).
- It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin, and soft tissue cancer.
Source: Genentech
BORUZU
FDA Approves Boruzu Ready-to-Use Injection for Multiple Myeloma and Mantle Cell Lymphoma
September 5, 2024 – Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. Food and Drug Administration (FDA) approval of Boruzu, a new presentation of bortezomib for ready-to-use subcutaneous or intravenous (IV) administration. This new oncology product reduces the compounding preparation steps typically required with administration. This product references the branded product Velcade , a lyophilized powder requiring reconstitution before use.
- Boruzu (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma.
- Shilpa developed the molecule and Amneal will manufacture and commercialize the product. Boruzu is expected to launch with a unique J-code in the second quarter of 2025.
Source: Amneal Pharmaceuticals, Inc.
Biosimilars
OTULFI™
FDA Approves Otulfi™, a Biosimilar to Stelara®
September 30, 2024 – Fresenius Kabi, and Formycon AG, announced the U.S. Food and Drug Administration (FDA) approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®. Otulfi™ is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
- Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses.
- Otulfi™ demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
- Otulfi™ was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.
Source: Fresenius Kabi
Generic Drug Approvals
- Drospirenone Tablets 4mg
Approved: September 30, 2024 – Lupin Ltd.
Indicated for: Contraception
Generic for: Slynd
Recalls
FDA is Alerting Patients and Health Care Professionals About the Voluntary Withdrawal of Oxbryta from the Market Due to Safety Concerns
September 26, 2024 – The FDA is alerting patients, caregivers, and health care professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety concerns. Health care professionals should stop prescribing Oxbryta. Patients and caregivers should contact their health care professional about stopping Oxbryta and starting another treatment option.
In postmarketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sickle cell disease receiving Oxbryta compared to placebo. There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these postmarketing studies. Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real-world registry studies.
Pfizer Inc., the manufacturer of Oxbryta, announced it is voluntarily withdrawing the medication from the market, ceasing distribution, and discontinuing all active clinical trials and expanded access programs for Oxbryta because recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population.
Source: FDA